New project proposal: Digital Local Heroes.

A project we are currently workshopping…


For UK residents looking for historical information, Wikipedia is invariably the go-to resource. The English Wikipedia alone has over 2.6 billion words, covering 4.4 million articles.  There are many examples of extremely rich, detailed, beautifully illustrated historical articles.

Unfortunately, Wikipedia also suffers from a systemic bias of editors. The average Wikipedian on the English Wikipedia is male, technically inclined, formally educated, aged 15–35, and likely employed as a white-collar worker or enrolled as a student rather than employed as a blue-collar worker.

This has the result that articles of local heritage are massively underdeveloped or missing.  Worse, the very people who are most passionate about local heritage are often inhibited by a lack of familiarity of technology, or inexperience with Wikipedia’s approaches.

We propose the Digital Local Heroes project.  We’ll provide the space, training, and expertise for groups of people to work together to improve the coverage of their local heritage sites on Wikimedia projects.  Their training will includes taking and uploading photos, drafting articles, producing sources, and all the skills that enable groups to make this difference to their local community.

Once users have been trained and have gained some experience in the use of Wikipedia, they will be much more confortable contributing outside of the project, making this an extremely sustainable approach.

As a form of ‘secondary gain’, we shall be focusing on those groups that are underrepresented on the Wikipedia Project, and groups that have much to gain from being involved.  The Digital Local Heroes project allows jobseekers to gain, develop and demonstrate a range of important employability skills such as research, copyright law, sourcing, non-fiction writing, teamwork, and proofreading  in addition to the obvious information technology skills.   Moreover the Digital Local Heroes project allows older people to stay engaged digitally, and to continue to give to the local communities in a way that gives them pride.


Our theory of change can be download here, and has been reproduced below:


Update on the Essex Challenge Prize

The 'care packages' we sent to care homes.
The ‘care packages’ we sent to care homes.

We’ve been working hard on the Essex Challenge Prize, and today we’ve done a fair amount of restructing of our online information about the project.

You can read about our plan, our progress, and how we are getting on by starting with this page on the eQuality Time wiki.  That will link you to all of our subprojects, Dropbox Directories, and research.

We’re trying to make more use of this sort of structure. Blog posts and tweets are all very good for showing the sucesses of an organisation, but we really want to show the steps we take, the errors we make, and show the complete narrative – and for that sort of approach you really need to be using public issues and wiki pages.  We hope you like reading about it!

Writing a Risk Assessment for Software

Recently we’ve spent a lot of time bogged down in medical device registration for The Open Voice Factory.

As part of this we developed a risk assessment around the software – looking at the potential causes of harm (i.e. “What happens if there is a fire in the house and our software fails to help someone speak to emergency services?”).   These sorts of documents are valuable but also pretty bruising – half the time you are making notes about features to add and test, and the other half of the time you are saying “We’d better make sure the documentation is clear that we don’t think that is a good idea”.

I wanted to share our first attempt more broadly (it’s already public because it’s on our public project board) because I think people might be interested, and I also think they might have some ideas for risks that we’ve missed out.

Please look at it here: OVF.risk.assessment.v0.2.

One of my ambitions with The Open Voice Factory is that we also make all the software tests public and easily understood (the first bit of that is easy, the second is hard) and then we can say “These are the risks we thought of, and the tests we wrote to check them, if you think of anything we’ve missed, let us know and we will add some tests”.

If we have a convincing enought test suite, then it also becomes possible to say: “If we don’t have a test for it, then you shouldn’t rely on it”.

Substandard Subtitles

After a short corraspondence with the wonderful Emma Colton, who writes the equaly wonderful The Happy Hearing Aid blog she sent us this amazing piece on the trials and troubles with dealing with TV subtitles.  I hope you enjoy it as much as we did. 

A few years ago, while still at University, I was a reality TV fiend. I couldn’t get enough of it. I would watch The Only Way is Essex (TOWIE), Made In Chelsea and Geordie Shore without fail. As I’ve gotten older, and more mature (I promise!!) I gave up these programmes for more pressing matters such as… getting my degree!

This year was all about trying new things and this meant I gave into my reality TV ban. I’d joined the rest of the world by watching Love Island. I had never watched a series before but, as most of my friends raved about how good it was, I thought I’d give it a go. I even went as far as to download the ITV Hub app in case I missed an episode.

Despite succumbing to the trend, I can proudly say I do not watch it religiously. I do need some down time though and therefore I attempt to watch it on ITV Hub online or on my phone app.

If you’re a regular reader of my blogs then you will know I struggle to watch TV without subtitles. I am so used to having them on the screen (much to my family’s annoyance) due to having lived with deaf people and I feel like it is a security blanket for me in case I mishear something as I often do when my ear infections returns.

So, let me set the scene: I’m snuggled up in bed with my cuddly toy that I’ve had since I was 2 (you’re never too old for your childhood teddies), with my PJs on and a soothing mint tea. I was all set to embark on the magical world that is trash TV and went online to choose the latest Love Island episode (I had missed it when it first aired).


The adverts were running and there was no option to turn on subtitles. I assumed as it’s just the adverts (not that that’s a good enough excuse) there were no subtitles as this is standard even at the cinema. I thought I’d just wait until the programme started.

Fast forward to 3 minutes and the opening titles have come on and and there are still no subtitles. In utter panic I turn to my phone and try to watch the episode on there. The same thing happened! There was just no option but to watch the programme without subtitles.

The mobile app and the website for ITV will only let you watch a show with subtitles once the episode is at least a day old, it is not ready straightaway. How is this useful to deaf people who want to be accessing programmes on ITV Catch Up? Why should anybody have to wait for subtitles if they need it? The fact a deaf person would have to wait until an episode is older than a day to get subtitles is OUTRAGEOUS!! I’ve been told in the past that some of my blogs can come across as angry… but…I am!

The whole point of Love Island is that it is on daily for you to see what the contestants have been up to on that day. This system that ITV have means people who rely on subtitles for access will always be one day behind everyone else which ironically reflects the perception of deaf people from the hearing world anyway. Deaf people are seen as behind mainstream children with language development, behind academically (even though deafness is not a learning disability) and behind on accessing information due to a delay from interpreters relaying information which is unavoidable.

In addition when the subtitles are working, they do not always match what is being said on the TV. Lots of things were missed out which means people relying on subtitles are not gaining full access to the show like a hearing person would.

Deaf educators and people who work in the deaf charity sector are working hard in trying to bridge the gap that deaf people face in a hearing world and society yet we are letting them and the deaf community down by removing something that is so easy to solve.

As the proverb says ‘curiosity killed the cat’ – I could not help myself but to go onto BBC iPlayer and see what they were offering the deaf community.

The BBC iplayer service has very clear categories displayed ranging from films to documentaries and ‘signed’ to ‘audio description’ – finally some accessibility!


I wanted to try these out for myself and started to watch ‘Who Do You Think You Are?’ from the ‘signed’ category – waiting for the signer to appear. Nothing happened. There were subtitles, but the whole point of the category is that there is British Sign Language being used for access.

People often say to me ‘Oh have you ever thought about being one of those sign language interpreters on TV who sign the news at 5am’? Everybody is aware of these irregular timings for interpreted programmes. It is a well known ‘joke’ in the hearing world and it shouldn’t be like this. I wish there was a TV remote that allowed you to press a button to activate a BSL interpreter. Who wants to join me in developing this and going on Dragons Den?

Not all deaf people have strong reading skills and the signing aspect on the programmes will allow people to access the show in their first language. This happened on three other programmes I had clicked on in this category. Some did have the intended signer, but it was not consistent at all.

During the World Cup the subtitles were very conveniently placed covering the score…


It meant that I had to turn them off to know what was going on score-wise. Being forced to turn the subtitles off means that deaf people are not accessing the commentary. We had waited four years for this – you would have thought someone would have realised placing them in this position was pointless!

Subtitles are a constant battle for the deaf community. There have been many recent petitions on this topic from access at the cinema to many complaints from the public on Netflix and how there are words missing from their subtitles. YouTube is an example of very poor subtitling as most of the time they are done through an automatic voice recognition system that mishears the words. I recently watched something where ‘keen’ came up as ‘key’. When you are hearing, you likely wouldn’t realise that this is wrong. As a deaf person, it is likely you would not be able to realise keen was the intended word. It is confusing and stressful. That deaf person would have to have a really strong understanding of English to realise it was not the intended work.

This needs to change, we need to have subtitles on programmes that are accurate, consistent and reliable. When will this become the reality?

I have previously written about subtitles in cinemas. To read more about this, please see: When going to the CinEMMA

Check out our new draft communication board for people with Dementia!

Screen Shot 2018-07-30 at 16.31.31

In May we were shortlisted in the Essex Dementia Challenge Prize.

Nine shortlisted projects were give £5,000 each to develop an idea, with the idea that the best idea will receive £100,000 to take it to market.

Our idea is: use the resources we’ve developed for The Open Voice Factory (particularly CommuniKate) to create a communication board that helps with word-choice (which causes significant problems in many people with late-stage-dementia).

Our first draft of the board has now be put together (it’s missing some symbols and we’re reviewing the language based on a very deep dive on the research), but you can check it out here.

If you’d like to follow the project more closely – we’re updating this github issue with all progress.

Do you have an emergency in Thailand? Then we are here for you!

Check out these amazing In-case-of-emergency (ICE) cards translated by volenteers in Thailand!  They are based on our CommuniKate ICE cards for people with speech disabilities,  You can download them from our Github repo, where you will also find the English version to use (or to translate!) .

Screen Shot 2018-07-11 at 21.16.14


Comic Relief have funded the Open Voice Factory!

Screen Shot 2018-07-11 at 09.16.27

Comic Relief and Paul Hamlyn Foundation are funding thirteen organisations to receive funding from their Tech for Good stream. eQuality Time is one of them! We’re receiving £45,000 to develop the Open Voice Factory, along with lots of support and guidance.  We have so many people to thank, and a sudden big responsbility.  It’s going to be amazing.

This means that the Open Voice Factory is likely to be our major project for at least the next nine months. While we have many funding bids in for other projects, they  won’t ‘mature’ (or not) for quite a long time.  Expect quite a lot of OVF focus from here on it.


Open source Medical Device Registration

Several years ago, at the start of the Open Voice Factory project, it became clear that we’d need to register the Open Voice Factory, or some part of it, as a medical device. It was publicised to, in the words of the relevant european directive ‘mitigate handicap’, and so it needed to be registered. There is NO moral way around that.

It also became clear that there were almost NO other open source medical devices. Or at least, none that could be found. The only documentation was largely incomprehensible and everything was guarded. Nobody had put their technical file online, almost nobody wanted to say what their technical file contained.

I swore that by the end of the process I’d write the document I wanted at the start.

It will be a while before I can write that post, but I promise that I’ll put everything relevent here in the meantime.

Currently, that’s relatively little (well, it’s 6,000 words, but most of the good content is at the bottom). But I try and give you most of the information I have.

As a result of the Nesta Prize we had £10,000 in fees we could give to consultant to help us through this process. We wanted to do everything right, and so we got professionals in. I’ve reproduced the majority of the correspondence (or at least everything that might be useful to another project like ours) below. It’s all entirely focused on our situation and, as written below, nobody takes any responsibility for the advice within.

In the coming months I hope to be adding our technical file to this post, as well as doing updates to the correspondence, and some content from the people helping us make the technical file.


This is the letter we sent to the MRHA originally:  MRHA letter.

04/06/18 17:12:

Here’s were we are at the moment. We’ve consulted with a developer who has experience taking software through medical device registration and who already has some familiarity with our work.  Here’s the understanding we now have:

To register as a medical device you must produce a technical file. Part of that technical file is about the organisation itself – how do you decide what features to add, how do you assess risk and so on.  To show this, we need to have a set of policies that cover the developement of the device, and, we need to be able to show that we are following them.  So the process looks like this:

  • Write and approve policies
  • Wait (while writing the rest of the technical file)
  • Check that we’ve been following our own policies (with evidence)
  • Add the evidence to the technical file and submitt.

Our consulting developer has recommended the following five policies (based on his experience, this isn’t a standard set):

  • Development,
  • Document Management,
  • Risk Management,
  • Continuous Improvement
  • Post Market Surveillance

Now, the medical device rules say that you have to have a ‘state of the art’ process.  It appears that you can either prove your own process to be state of the art, or follow one of the International Standards, on the basis that it’s understand that these standards establish the state of the art.  The relevent standards here appear to be:

  • IEC 82304, 6
  • ICE 2304
  • ISO 14971
  • Possibly  ISO 13485

The standards aren’t publically availible, in fact they are expensive to purchase, which is one of the other barriers to Open Source Projects getting medical device status.    In any case they have statements like “There should be a throught process for X”, whereas the policies say “Our process for X is” so there should be some flexbility.

We’ve tracked the process of producing these policies in this github issue.

30/07/18 17:12:

Okay, the policies have been produced, we’ve been implementing them happily, and we’re now at the point of creating a technical file, which in summary is “The policies and the evidence that we are following them” but which actually contains a few more bits. Our ongoing issue for this is:



It started with:

Jul 11, 2016, 3:44 PM

The first of the emails

Hi Colin, 
Great to speak to you on the phone last week.  I’ve included some information. 
Here are two other software systems that do the same thing, but are paid for:  and .  (There are a wide range of other manufacturers – but they produce the hardware as well as the software, so I suspect that would be difficult to untangle).
What’s the next step? 


Sep 20, 2016

(I had sent several follow ups)
Hi Joe
Sorry for the delay in getting back to you and thanks for the follow up. I’ve reached out to a member of our consulting team to get their feedback as to whether or not your technology is likely to be considered a medical device in the EU. I’ll be back in touch as soon as I have their feedback.
followed by:

Hi Joe

I’ve just received the following feedback from our software consultant. I asked him if he thought your technology would be regulated as a device. He noted:

‘Possibly – from the MDD :  “compensation for a handicap” .  Neither of the 2 competitors below mention anything about regulation / consideration as a medical device !

From MEDDEV 2.1/6 – if the software only communicates data, then it is not covered by MDD.

There are 2 questions: is enabling speech is a medical benefit to the patient ?; does the device do more than communicate data ?

I think it would be worth asking MHRA’

If you could provide feedback on the two underlined questions we can consider further.

Kind regards


Thu, Sep 22, 2016, 3:12 PM


Very much depends on the definitions.   So enabling speech doesn’t change anything from a medical point of view – (except in the sense that you can tell your doctor that you are feeling faint, or having stomach pains), it’s all about social interaction enpowerment and so on.  Obviously there is a knock on effect on mental health, but I’m assuming that isn’t what is being asked. 
For the second question: 
Depends what you mean by data – the device *could* track usage information and record data in that sense. but in real terms – NO really.  Certainly if there is a hardish or fastish rule then we could design around it… 
Does that make sense? 
For your interest – here’s a video of the tech in use…

Tue, Oct 4, 2016, 8:44 AM

Given the borderline nature of your technology I think we would recommend sending an email/letter to the MHRA to ask for their opinion on the classification. Just in case you don’t know the MHRA are the UK Competent Authority
We can help draft the correspondence but its always better if it comes from the manufacturer. I’d estimate it would take no more than 4-5 hours work (at £150ph) to prepare the correspondence on your behalf if you’d like to proceed this way.
Kind regards

Tue, Oct 4, 2016, 11:31 AM

Let’s do it.  What’s the next thing you need from us?

Fri, Oct 7, 2016, 12:20 PM

Hi Joe
Here is the short proposal and agreement. If you’d like to proceed could I ask that you sign and return both?
Kind regards

Wed, Oct 12, 2016, 4:59 PM

Signed and attached 🙂 

Mon, Oct 17, 2016, 4:43 PM

(Some emails removed because I hadn’t filled out the form properly…)
Thanks Joe. Our project management team will be in touch shortly to introduce the consultant who will pick up the work.
Kind regards

Oct 18, 2016, 2:42 PM

Dear Mr. Reddington,

 I hope all is well. My name is Patrice and I am part of Emergo’s project management team coordinating your Device Classification project. I would like to thank you for entrusting Emergo with this project. My primary job function is to ensure that all project related work progresses successfully, so please feel free to contact me if you ever have any concerns regarding your account. Below I would like to discuss some project details with you. 


As per the proposal the scope is currently defined as follows:

Emergo provides support with device classification for AzuleJoe (5 budgeted hours). 

  1. E-Quality Time Limited wants to determine if the technology would be classified as a Medical Device under the Medical Device Directive (MDD).
  2. Emergo will prepare a document to be sent to the UK Competent Authority (MHRA) to ask for their determination of the classification.
  3. It is recommended that E-Quality Time Limited send the final document to MHRA as this, in our opinion, solicits a better response.

<some information removed as it pertains only to Emergo’s internal workings>


Wed, Oct 19, 2016, 9:19 PM

Hello Joe,

I have the links and information provided to Colin in September.

I assume I should prepare the MHRA enquiry from the perspective of AzuleJoe *not* being a medical device ?

Kind regards


Thu, Oct 20, 2016, 3:46 PM

Hi Brian,
That would be nice for us,  but the most important thing is that the decision is correctly made and gives some cover for any future developers doing the same thing.  🙂

Thu, Oct 20, 2016, 3:57 PM

Thanks Joe – I will reason the classification using the MHRA guidelines, so that the view we present is clear – and hopefully the MHRA will agree – but point out flaws if necessary.



Sun, Oct 23, 2016, 9:06 PM

Hi Joe,

I’ve worked through the MHRA guidance again – please see my discussion doc attached, and the MHRA guidance.

The key question is on the medical definition of what azuleJoe does for a user – if the phrase “Compensation for a handicap” is appropriate for enabling speech, then the device is considered a medical device !

Based on this assumption, it would be class I, which is a low regulatory burden.

Please review and comment ?  if a call would be a good idea, please suggest a time on Tuesday ?

Kind regards


Tue, Oct 25, 2016, 1:34 PM

Hi Brian, 
One minor thing – although most accesses will be by tablet-  the Open Voice Factory itself is a website.  
Any time good for a call in the afternoons.  My mobile is 07703683028. 

Fri, Oct 28, 2016, 9:29 AM

Dear Joe,

Please find attached the letter for the MHRA.

I suggest you could send to X  – who has responded to prior requests about software.

Kind regards,


(some hangling on the langage of the letter, the version I sent was this one: MRHA letter).

Mon, Nov 7, 2016, 1:25 PM

Hi Brian, 

Just wanted to check in on a few things while we wait for a reply from the MHRA, 
I’ve got some funders to report back to – and they are interested in timescales – I know this is a movable feast, but in your experience, could you tell me what a ‘fast’ and ‘slow’ timescale might look like? 
The other thing I wanted to give a small head’s up on – we’re an open project and thus need to make sure that we are communicating what we do widely, I’m assuming quoting emails from you guys  and so on is all fine – if there is any issue with that do let me know. 

Mon, Nov 7, 2016, 2:50 PM

Hi Joe,

Timescales on response from the MHRA should be in less than 4 weeks – but no knowing !

After that – if CE mark is required, it can be done fairly quickly – your technical team would do most of the work, but the technical file could be assembled in 2 or 3 months.

In terms of quoting – it might be best to check what you want to quote – we issue disclaimers that information provided is solely for the particular customer, and information for you may not be applicable to a wider audience.  In the regulatory space, it’s seldom a case of “one size fits all” !



(consider yourselves disclaimed)

Thu, Nov 10, 2016, 3:27 PM

Hi Brian,

It was in the contact of quoting email conversations when writing up the process of licensing ourselves as a medical device for our blog.  Does that make sense?

Thu, Nov 10, 2016, 7:33 PM

Hi Joe,

Yes – and I think that would be fine if you acknowledge Emergo as the source.



(included only because you’re reading that very blog)



Thu, Feb 2, 2017, 1:21 PM

Hi Brian, 

MHRA have come back to us with:

“Dear Joe,

Firstly I must apologise for the lengthy delay in replying to your enquiry due to unforeseen staffing issues.

With regard to your letter we would tend to agree with your opinion that the product is likely to be a Class I medical device under Rule 12.


Rob Higgins

What’s the next step? 

Thu, Feb 2, 2017, 1:40 PM

Hi Joe,

This is a typical MHRA response – they don’t give a strong opinion !  This is perhaps a borderline decision, and the only way to get a firm opinion would be through the courts.

The next step would be to build up a technical file, on the basis of which you can sign a declaration of conformity and apply the CE mark to the product.  

If you’d like Emergo’s assistance in this process, I can request a proposal be sent to you .

Kind regards



Thu, Feb 2, 2017, 1:48 PM

That’s interesting – when you say technical file – what would that look like?


Thu, Feb 2, 2017, 3:06 PM

Hi Joe,

A technical file is a summary of the product – how it works, and for a product like this will be about 20 documents, written to comply with 3 standards – risk management, software life cycle development and usability. A few of the documents address regulatory requirements.

Kind regards


Tue, Feb 7, 2017, 12:40 PM

Cool,  do you have an example laying around somewhere can we could use to get our heads in the right place for moving on? We also need to start talking about US regulation as well.



Wed, Feb 8, 2017, 9:16 AM

Hi Joe,

There is no “one size fits all” – but below is a typical list of documents you would expect to see in such a tech file:
User Requirement Specification
Software Development Plan
Risk Management Plan
Risk Analysis Report
Software Requirement Specification
Verification Test Plan and Specification
Verification Test Results
Validation Test Plan and Specification
Validation Test Results
Trace Matrix
Usability Engineering Plan
Release note
Labelling note
Essential Requirements Checklist
Declaration of Conformity
Technical File Table of Contents
Clinical Evaluation Report
Usability Engineering Report
Release Design Review

Kind regards

Wed, Feb 8, 2017, 12:19 PM

Cool. We’ll get started – what’s our next move in terms of the US?


Wed, Feb 8, 2017, 12:29 PM

Hi Joe,

We need to identify a predicate device – a similar device already in use in the USA – can you suggest one/more ?

With this info, I can check to advise what will be required.

Kind regards


Wed, Feb 8, 2017, 12:42 PM

Hi Brian.

The single most obvious example are  prologue2go (as an app)  ( and CoughDrop ( as a website. Sound good?

Thu, Feb 9, 2017, 11:59 AM

Hi Joe,

I’ve searched the FDA databases – and not found anything related to speech or speaking assistance. This leads me to assume that such a device would be 510k exempt or un classified – and the only way to confirm this would be to submit a 513g to the FDA which is a request to confirm classification, which is difficult here as we don’t have one !

Neither of the 2 you listed below show up !  so I suggest that we submit an RFD to the FDA

There are still some hours in this project, and I could draft and send such an RFD in an hour or so – let me know if I should proceed.

Kind regards


Thu, Feb 9, 2017, 12:29 PM

That would match our understanding.   Please do 🙂


Fri, Feb 10, 2017, 7:06 AM

Hi Joe,

Emergo colleagues advised that an RFD is for a combination device, and a better option would be an email – which I’ve sent off – see below…  we should get an answer in a few days…

Kind regards



Dear sir/madam,

We are assisting a company (in the UK) that has developed a speech aid for those who are unable to speak. The device is software, running on a tablet or similar computing platform.

The user indicates what they want to say by selecting icons on a touch screen, then the software builds a phrase or sentence which is digitally generated and played through a loudspeaker for others to hear.

The device may be viewed here:

The device is considered a medical device in some countries, and the company would like to know if this device is considered a medical device by the FDA, and if so, a classification for the device. We have searched the FDA classification database, under the Ear, Nose, Throat panel, but not found any suitable product code.

We would appreciate your assistance,

Kind regards,



Tue, Apr 25, 2017, 9:29 AM

I’ve removed a bit of haggling where I was asking for a summary that I could give to funders.  We ended up with this, which I’ve included as a fair summary.


Hi Joe,


Ok – my text can be as follows:


CE Marking

The MHRA have confirmed that the device can be classified as a Class I medical device. CE marking for a Class I medical device is a self-declaration, based on a technical file against which a declaration of conformity can be signed by the manufacturer.

FDA clearance

It is not clear whether the product requires clearance from the FDA. Accordingly, we have submitted an enquiry to the FDA seeking clarification. The standard FDA response has been that “this evaluation process may take 60 or more days”. Other than a request for an update, we are not able to advance the FDA clearance process at this stage.

If this text is sufficient, I can apply to a letterhead. It will need to go through a peer review process within Emergo, which may take a day or two.

Kind Regards


Mon, Jun 12, 2017, 3:22 PM

Hi Brian, 

I’ve been reviewing the project here and I wondered if you could help us out by answering a couple of questions? Some are for internal use, but most are so that we can answer questions that we are getting: 
  • What is the penalty (other than being sued if it goes wrong) for failing to register a device.
  • What happens when we change the code (as in, fix a bug or add a feature)? Do we have to re-register?
  • Does porting an app to a new piece of software need another registration process (i.e. do we have to do this seperately for iPhone and Android devices)?
  • Are there any examples of tech files anywhere?
  • Is there an open list of other devices that are registered as medical devices? How much information do companies/regulators have to publish on the topic?

Mon, Jun 12, 2017, 7:51 PM

Hi Joe,

See responses below…

Kind regards



  • What is the penalty (other than being sued if it goes wrong) for failing to register a device. – I don’t know – would need to check with MHRA / lawyer
  • What happens when we change the code (as in, fix a bug or add a feature)? Do we have to re-register?  No – just sign a new DoC for major revisions
  • Does porting an app to a new piece of software need another registration process (i.e. do we have to do this seperately for iPhone and Android devices)?  – only if intended use or mode of operation changes. You can define the product as multi-platform
  • Are there any examples of tech files anywhere? Not sure – but there is a guidance – attached
  • Is there an open list of other devices that are registered as medical devices? How much information do companies/regulators have to publish on the topic?  Not much !  MHRA has a listing of class I devices, but there is no detail other than company name




Fri, Jul 7, 2017, 10:38 AM

Good afternoon Joe,

I hope you are well.  I am emailing with a quick project update.

Brian last checked in with the FDA in May, but we have still not received a response.  They did indicate that it could take 60 days or more, but we are uncertain when or if they will reply.  How would you like to proceed?  Would you like us to send another reminder?  Please advise.

Project hours: 3.75 hours worked (1.25 hours remain).

Thank you!



Fri, Jul 7, 2017, 12:48 PM

HI Patrice,

Yes, please do 🙂

Fri, Jan 19, 2:51 PM, 2018

Good afternoon Joe,

I hope all is well. I am emailing to inform you we did not receive any response to our follow up with both the Device Determination distribution group or (only an automated response). We had also reached out internally to another colleague in the US (who suggested DICE) and she commented that it is unfortunate they did not respond and they have had more than enough time to do so. I have noted that this has also occurred in at least 2 other projects where we sent emails for feedback and I am not certain what the reason for their unresponsiveness may be.

At this time, I wanted to check in to see if you would like any further assistance under this proposal (161007-57210)? Or how would you like to proceed? There are still 1.25 hours remaining.

Thank you!


Tue, Jan 23, 2018 5:32 PM

To clarify – is that ‘of the three projects we have doing this, none have received a reply’ or ‘of the 30 projects we have doing this, three haven’t received one’ ?

Wed, Feb 14, 2018 11:24 AM

Good afternoon Joe,

I hope you are well.  My apologies for the delayed response.  We have not tracked this for all offices, so I meant in my experience we had this happen a few times (so probably more along the lines of 3/30 although this would be a guesstimate as I do not have numbers for informal FDA email inquiries sent by other offices/Project Managers).

However, as I mentioned, we still have a bit of consulting time left so we would be happy to continue to try to outreach to the FDA to try to push for a response.  Please let us know how you would like to proceed.

Mon, Feb 26, 8:31 PM

Please do.

One other thing: I have to provide a, I think, ‘tech file’ to the UK medical device people but I have NO idea where to start making one.  Do you have an examples or case studies laying around that might provide a starting point for us?

Tue, Feb 27, 1:18 PM

Good afternoon Joe,

Thank you for your reply.  I will let Brian know to try another outreach to the FDA.

Regarding your other inquiry, I will put you in touch with my colleague in Business Development, Mr. Rehema Mussanzi (in copy), who can assist with providing information on Technical Files and what Emergo can offer to support.

We also have a resource library on our website with some free information to get you started.  For example a white paper on Preparing a European CE Technical file for a Medical Device or a video on In-Depth: Europe CE Marking Medical Device Approval and Compliance with a brief segment on preparing a Technical File.


Wed, Feb 28, 6:13 PM

Awesome, will look forward to hearing form Rehema


Mon, Mar 5, 7:38 PM

Hello Joseph,

Thanks for requesting the whitepaper about European Tech Files. Please click this link to download (PDF):

For additional information about Europe, check out our Library:



Monday, 23 April 2018 3:56 PM

(first ever response from the FDA – sent to Emergo rather than eQuality Time)

Dear Brian Goemans,

Thank you for contacting the Division of Industry and Consumer Education (DICE) at FDA’s Center for Devices and Radiological Health (CDRH) e-mail account.

If your product meets the definition of a medical device, it will be regulated as a device.

A medical device is defined in Section 201(h) of the Food, Drug & Cosmetic Act (FD&C Act; or 21 USC 321(h)) as “an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component, part, or accessory, which is … intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or [which is] intended to affect the structure or any function of the body of man or other animals … .”

Other useful information on device determination can be found at the What is a medical device, Is The Product A Medical Device and the Device – Not a Device webpages.

For regulatory information about your medical device of interest, please search the Product Classification and Establishment Registration & Device Listing databases to check if a device similar to your product is listed with FDA.  I found a list of speech related devices on the Product Classificationdatabase. You can use this database to search for other products you plan to import into the U.S.

If you are still unable to determine whether your product is a medical device, please contact the Center for Devices and Radiological Health (CDRH) Device Determination Officers, Office of Compliance, via e-mail for their determination. Within your email, please include a complete description of your product and its intended use, as well as any draft promotional material and labeling that you might already have.  Please note that they do not determine the classification of a device nor do they determine whether a premarket application is required.  The Office of Compliance will only provide their determination of whether or not your product is a medical device.

If you have more software specific questions I would recommend you email our software experts at

Meanwhile, here is a list of digital health related references.

Meanwhile, I will provide you with information on how to market a medical device in the U.S.

Registration and Listing

To register with FDA, please review the Device Registration and ListingWho Must Register, List and Pay the Fee webpages and follow the instructions on How to Register and List. You should also review information on Entry Process and Importing into the U.S.

It is the responsibility of manufacturers to classify their medical devices.

Medical devices are classified based on intended use, risk and the level of control necessary to provide reasonable assurance of their safety and effectiveness. There are three regulatory classes of medical devices: Class I, Class II, or Class III. The regulatory class of a device type is defined in Section 513(a) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(a)). Review the information on Regulatory Controls to learn about the types of regulatory controls applicable to each class of medical device.

If you need help with classifying your device, you can submit a Request for Classification (513(g)). The 513(g) request fee is on the FY 2018 MDUFA User Fees list. If you wish to directly contact the Office of Device Evaluation, please refer to the CDRH online directory for the appropriate contact information.

If you qualify as a “small business,” you will be eligible for a reduced fee for some types of CDRH submissions that require a user fee. Please review theSmall Business Determination Program webpage, and the FY 2018 Medical Device User Fee Small Business Qualification and Certification guidance document for information regarding eligibility and the application process. A small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year.

If a device requires premarket application submission, the owner or operator should send to FDA the required premarket submission such as: Premarket Notification 510(k), Premarket Approval (PMA), Humanitarian Device Exemption (HDE) etc. Review How to Study and Market Your Device for information on premarket submissions. Note that most Class I devices and a few Class II devices are exempt from the premarket notification 510(k)requirements, subject to the limitations on exemptions. Please review theMedical Device Exemptions requirements.

Finally to legally market a medical device in the U.S., manufacturers must register their firms and list their devices with FDA. Manufacturers also have the opportunity to market devices, which do not require a premarket submission, for up to 30 days before they register and list with FDA.Registration is done annually. It is the responsibility of manufacturers to meet all FDA requirements before registering and listing. Importers too should register with FDA, but they do not have to list products. Importers must ensure that their foreign manufacturers or vendors have registered and listed with FDA. Foreign firms exporting devices to the U.S. should have a U.S. based agent. For more information on marketing a device in the U.S., please review the Overview of Device Regulation, and CDRH Learnwebpages.

The Annual Establishment Registration Fee for FY 2018 will is $4,624. See FY 2018 MDUFA User Fees.

Please note that not all medical devices legally marketed in the U.S. are considered FDA “approved.” The term FDA “approved device” specifically refers to Premarket Approval (PMA). PMA devices are usually Class III devices. Similarly, the term FDA “cleared device” specifically refers toPremarket Notification 510(k). 510(k) devices are usually Class II devices and a few Class I devices.. Manufacturers are not allowed use the terms “approved” or “cleared” to describe devices that have not successfully gone through the respective PMA and 510(k) submission processes. Devices not requiring premarket submission can be marketed if a registered manufacturer lists them with FDA. Manufactures can also market such devices up to 30 days prior to listing them with FDA.



Division of Industry and Consumer Education
Office of Communication and Education

Center for Devices and Radiological Health

U.S. Food and Drug Administration


Wed, Apr 25, 10:58 AM


Hi Joe, 

It’s been a while – but at last there has been a response from the FDA !

Unfortunately the response has come from DICE – a response from Device Determination would have been more helpful !

However, referring to the definition below (linked from the email)

(h) The term “device” (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is-

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and

I suggest that it would be reasonable to state that a speech aid does not fit in the definition of 1-3 above, so is not a medical device.

Please consider this email below, and provide feedback ?

The interpretation above is informal – Patrice is away this week, but when she is back next week, I will discuss the next step – in Emergo an internal peer review is required to provide a determination of your device being a medical device or not.

Kind regards


Thu, Apr 26, 10:56 AM

That’s somehow worse… I’d assumed they’d burned it, rather than this simply the length of their backlog.

Let’s see what Patrice thinks…

Fri, May 4, 2:39 PM

Hi Joe,

I hope all is well.  I have not had any other informal device classification inquiries (for other clients) since last year, so I am not certain if they are having a substantial backlog.  I can ask again internally with our US team if they have any recent feedback. I am also wondering if the FDA had just crossed it off their list (or forgot about it) until Brian sent a follow up.

I see that Brian has suggested that it would be reasonable to state that a speech aid does not fit in the definition of 1-3 below, so is not a medical device.  If you would like for Brian to research this further to make a formal (peer-reviewed) report and opinion, we could add around 4 hours to the project via a scope change.

Please let us know how you would like to proceed.

Best regards,



Tue, May 8, 3:12 PM

Bit confused, is that:  “Brain can spend four hours writing a report for you” or “Brian can spend four hours writing a report and sending it to the FDA”?


Tue, May 8, 3:40 PM

Brian can write a report for you.  He can do a more in-depth research and provide a formal advice/standpoint (from Emergo’s point of view).


Tue, May 8, 3:46 PM

I understood we are paying you because you know this area already.  Why do you need four more hours to make a recommendation?

We put a lot of faith in you, on a project that is incredibly important to us, and it looks a lot like we have nothing to show for it.

Tue, May 8, 4:21 PM

Hi Joe,

We certainly understand your frustration as the FDA did not provide conclusive answers.  I can assure you that your business success is important to Emergo and we endeavor to support you however possible.

The initial proposal (161007-57210) was for Emergo to determine if the technology would be classified as a Medical Device under the MDD.  Emergo recommended preparing a document to be sent to the UK Competent Authority (MHRA) to ask for their determination of the classification.  We had up to 5 hours budgeted for this activity.  Brian provided this deliverable (classification letter for the MHRA) in October 2016 and MHRA feedback was discussed in Feb 2017.

After the initial deliverable was completed, you engaged Brian to assist with reviewing US regulations under the remaining budget.  Brian conducted a search of the FDA databases/reviewed competitors and, not finding anything related to speech or speaking assistance, determined the next logical step would be to submit an informal request for determination to the FDA.  Brian drafted and sent the initial email to FDA Device Determination along with numerous follow-ups last year, finally drawing a conclusion from the FDA feedback we received that it would be reasonable to state that a speech aid does not fit in the definition of 1-3 the FDA had listed, suggesting it may not be a medical device. Since there was limited budget from the initial ad hoc, Brian could not conduct a more in-depth review and instead supported as I’ve outlined here.

In order to provide an alternative approach to continuing to contact the FDA repeatedly (to no avail), we proposed a formal Emergo report.  We base our approach on the experience we gain across many projects, but we do bespoke research and write reports for each customer since we cannot and do not claim to have the same understanding as the regulators.  Therefore, we quoted the additional hours.  Typically for a regulatory research project (from scratch), we quote up to 20 hours, so the 5 hours we quoted here took into account that Brian was already familiar with your product and had been working on the MHRA and FDA requests.

We look forward to your feedback on how you would like to proceed.

Best regards,






Real Flexible Work

In an team with real flexible work you would be able to shut your laptop at any time without any guilt.

There’s lots of reasons you might want to. Maybe you are sick. Maybe someone you care about is sick. Maybe you want to spend some time on your mental health and maybe someone has broken into your house and you need to ring the police. The reason isn’t important. What is important is that you know the system will be fine.

We know this is possible because Wikipedia works that way. So do the writing camps that we run in schools: sometimes students are sick, or suddenly expelled, or drop out. The system continues.

I want eQuality Time’s work to be real flexible work as far as it can.

To make that happen, we have to build it in from the start. Here’s what we need to be doing:

No hiding
Unless a file contains confidential info (in almost all cases this means ‘personal information about an individual), it is shared. All our files are in Dropbox or Google Drive. No exceptions.

Always act like someone else will be the next person to work on this
eQuality Time uses github issues to manage our work. On each issue we (try to) list all things we need, and the steps needed to meet the goal. If we’ve done that right, then someone else can come along and say “Oh, this is a funding application – I see they’ve created the folder in Dropbox and marked that off, and the next thing to do is to copy and paste the question information into a new word file – I can do that for them”. If we act like someone else will do that, then we get really good at writing specific plans.

No locking
We never write: “I’m going to do X” on an , because then the project needs you before it can move forward. Instead we write “The next thing to do is X”. That way someone else can do it when they have a free moment. You might have been looking forward to doing X, or you might worry that someone else would do X wrong – in which case you should either have done X or you should give so much detail about X that it’s hard to do wrong.

Rewrite a process every time you follow it
There are lots of activities that we do again and again. A good example is publishing books from White Water Writers. For these activities, we’ve put the list of steps and advice into a wiki so that people don’t have to work it out every time. The important bit is this: when you are working through a process on the wiki, you should also be rewriting it. This might be because you are dealing with a special case, or because there’s something you missunderstood at first and you want other people to be warned, or because you want to add photos or reword. You might be rewriting it because you want to do it a bit differently this time and that’s fine. We rewrite so that the next person to follow the process finds it easier, and also so because it keeps us honest.

We work on the most important action first
If we have real flexible work, then we have NO locking. Without locking, it’s impossible to know what you are going to work on before you log in. Someone might have logged in overnight and finished off the last project you were looking at or someone working on an important project might have fallen ill. So when we log on, we should look at the most important project first (they are sorted by importance).

By definition, working on the most important project is the most important thing to do.

The last person to work on it should have followed “Always assume someone else will be the next person to work on this” and there will be a written down action for you to take. If it’s something with a process (like publishing a book) then it’s easy for you to do the next action and move the project along. If there isn’t an action written, then it’s worth pinging Joe (or, in future, the person on call) and finding out what the action should be. Work on the second most important issue while you wait.

Bottom line
Of course, there are deadlines. This system only works if there is someone that you can pass the work onto. Or, someone who is senior enough to say “Okay, we can drop that ball”. At eQuality Time, both of those people, are, sooner or later, Joe. Sometimes he might make the call to abandon a project – because we put worker’s heath above projects. Sometimes he might do it himself. But there is somewhere that the buck stops.

The funding applications that made us a better charity (even when we didn’t get them)

Screen Shot 2018-04-20 at 16.12.29
People who manage funds that give money to social projects are, by definition, great people having to make hard choices about the best place to put money.
It’s also important that people who manage funds keep to the lowest possible overhead.  It takes money to keep applicants up to date and give feedback and we accept that it’s often the best choice to save money there.
Some funders do provide a lot of support when you apply to them, even without the money. And that support can really make your organisation better. If you are a new organisation, then these are the funders you should apply to early.
This post has two aims:
  • Give other organsiations some pointers on which grant funders will help their organsiation get off the ground fastest
  • Give me an oppertunity to review our funding bids and see if we should change strategys
Most of eQuality Time’s money comes from grants. This means we have to apply for a lot of grants. I’m going to list the applications we made in the last 12 months and talk about how much developement was involved.
I’ve also been making notes on how much time I spent on each application, so I’ll also talk about if I felt that the application was worth making compared to other funders with shorter processes.
I find short application forms followed by interviews are much more developing than a long application form.  They are also quicker and cheaper (for you, NOT for he funder), and much much more fun (for you, probably NOT for the funder).  An interview can be hard, but if you have trouble answering the questions it’s a sign you need to make your idea better; go home and make the changes to your idea so that the answers are easy. Some interviews are better than others – there is a difference between “I am assessing your project and making a recommendation to the final panel” and “I am working with you so that I can best sell your project to the final panel”,  if you get one of the second type you should take all the notes you can.
So, let’s look at the what I’ve been working on.

Children in Need

This year I’ve spent an hour and ten minutes updating an application to Children in Need before I found I needed to spend time elsewhere.  It’s in this list because a) I did spend some time on it and b) last time we applied, we found it very useful.  Going through the Children in Need application meant that our Child Protection processes, training and policies  got a serious bump. We’ve never had any funding from Children in Need, but they were good for us.  They also have an assessment interview, which is always excellent.
Will be applying again.

Comic Relief Tech for Good

First Application
The Comic Relief Tech for Good application was fun (make a video and fill out a simple form). It took 5 hours 16 minutes, was written by someone who understood what the sort of projects we produced, and, importantly was run by the sort of people who are really easy to reach and ask questions of.   It was a nice process to go through.
We got through to the shortlist,  and so were required to do a training day and two half day interviews (both of which could be done over Skype.  That’s a fair investment of time, but both worthwhile. Training days mean meeting other shortlisted projects, all of which were interesting, and the interviews made our organisation better (“Do you have a reserves policy?” “No, but we will send you one within a week”).  Comic Relief also had a technical person in the room for one of the interviews, which is something I think all funders should have: there’s less confusion, it’s easier to concentrate on the idea, and I suspect it is easier for Comic Relief to detect when applicants are talking rubbish.
We don’t know if we will be funded by Comic Relief, but certainly we’ll happily be applying to the same stream in the future.

Lloyds Bank Social Entrepreneur Start Up

Initial Application.
The first application form too the Lloyds Bank Social Entrepreneur Start Up  about 5 hours 20 minutes (not including other staff members who prepared files or reviewed), and now I look back over it I filled it out very casually.
After being shortlisted there was an interview with an funder who complained about a funder-related blog post I’d written. I remember being quite impressed that the assessor had taken the time to read our blog.  The interview that followed was thorough and made sure that we had ticked the right boxes. I recall that the project came out much as it had gone in, (we  weren’t given money) – I think that’s because it was a well-established project with a solid plan – had we gone with a different project it probably would have been really useful (although less likely to be funded).
Would recommend.

UNICEF Innovation Fund

Initial Application
The Initial Application took 8 hours 55 minutes (not including other staff members who prepared documents or reviewed).
We were one of eight or so projects shortlisted, the full application that followed took another 35 hours 3 minutes. (not including the excellent work of other people on the bid team) plus interviews held at very short notice.   We eventually found out that we didn’t get it by reading the press release congratulating the successful teams.  No feedback at any stage (the interview was of the ’same questions asked to every candidate’ variety).
Given the amount of time  (and in this case, social capital) taken for the bid, it wouldn’t really make economic sense for us to bid for against a similar structure again.  It also simply wasn’t fun.   It’s only in reviewing the last year of bids that I realise how many other bids we dropped to get this right.
Building a Stronger Britain Together
First Application
This was an interesting one: the first application was to the Home Office, took 4 hours and 17 minutes and it was near-impossible to find any help, or work out who to talk to with questions.  We stuck with it because it was the first funding we’d seen that really matched up with the purpose of the Supertitle Project
(Shortlist might be the wrong term, all bidders might have been shortlisted)
It turns out that the Home Office contracted another group to do the fund admin, and so shortly after the application was made I got a call on my mobile from a smart funding officer who had many relevent questions and had clearly read the bid in detail. She pushed me on some details of the research background that should have had evidence and let me spend some time correcting any absenses in the application.   Was actually very pleased with this stage.
We are yet to find out if we got the funding, but it’s been mostly positive so far.

Arts Council

Our consistent applications to the arts council are best read about in another post. In total I’ve spent exactly eight hours on rebids in the last year.   Once you get over the first round, the feedback you get is quite good – it focuses on the bid rather than the organisation (or at least, our feedback does).  I will also say that the Arts Council staff are very helpful when you ring them up.

Virgin’s #iwill Take Action Fund

We wrote a fair amount about the application process here.  It was a relatively simply application process that took up three and a half hours of my time, but lots more from volunteers and staff. Pleasant, but we’ve had no feedback and didn’t develop the organisation (which, as I wrote in the beginning, is totally fine)

Reducting Social Isolation Fund

This is here for completeness – I worked on it for two hours and one minute, then dropped it to work on the UNICEF bid above.

Henry Smith

I’ve got four hours and three minutes marked for the Henry Smith Charity.  My notes tell me that two other people worked on it, for about the same about of time.  The application form itself was relatively simple, but I recall there being something strange about the form – a heavily restricted Word document if I recall.   Henry Smith also requires application forms to be posted, which was a headache – I assume it helps them cut down on applications, but I also feel like there are better ways to do that. We got a form letter back telling us that we weren’t getting funding.   In hindsight – applying to a fund that requires application forms to be posted probably isn’t an ideal stratergy for a charity that designs very technology focused interventions…