Digital Healthcare - QMS requirements

Daliane

Starting to get Involved
#1
Hi all,
developer of digital healthcare apps are usually unaware of regulatory requirements in the beginning, mostly because they are unaware that the product may be classified as a medical software.
How can a manufacturer deal with a situation, where an app has been developed, but no QMS (QSR or ISO 13485) has been followed? Can a QMS be established meanwhile/afterwards to implement applicable procedures like post-market surveillance, risk management, etc.?

Trying to figure out what the minimum regulatory requirements are for developers of health apps. What procedures & standards apply for digital health apps?

Thank you for any feedback & suggestions.

Regards
Daliane
 
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shimonv

Trusted Information Resource
#2
Hi Daliane,
You are touching on a very broad topic so it's not feasible to answer it all in one post. I have three things to point out:

1. When you develop a product you should always start with strategy, and that includes regulatory assessment of whether you product is a medical device or not.
2. A QMS can be established gradually alongside the development efforts.
3. If you made a wrong assessment on whether your product is a medial device or not and have completed its development, you have to reconstruct the design history files with the mindset of a medical device and build an fitting QMS. It might be easier to think of what you did a a prototype and now you are moving forward with the development for a commercial grade product which must fulfill the applicable regulatory requirements. The 'commercial product' will be better than the prototype.

Good luck
Shimon
 

Watchcat

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#3
1. When you develop a product you should always start with strategy, and that includes regulatory assessment of whether you product is a medical device or not.
Toyota doesn't ask itself whether its new model is a medical device. The only product developers who ask this question are those who are in the medical device industry. This is one reason I have no enthusiasm for software in healthcare; most of the developers are not in the medical device industries and are medical device naive. That makes them dangerous in my book. Moreover, once they hear that their app might be a medical device, and therefore regulated, their reaction is often denial, rather than inquiry.
 
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Watchcat

Trusted Information Resource
#4
Pretty much the only parts of the QSR and ISO 13485 that apply during development are design controls. Amateur medical device startups frequently ignore all or part of them during development and generate "just paperwork" retrospectively, as shimonv describes. When it comes to software startups, often the startup isn't even an experienced software startup, or experienced anything else, sigh. Lots of "student projects" in this space. Professional software developers can and will follow design controls without a regulatory agency or standard telling them to, starting with a definition of user requirements. Unfortunately, the software developers usually don't have control over how the user requirements are established, but at least they will assure that the fake user requirements are established up front, rather than after the fact., and then will follow them in developing the software.

There are a number of risks associated with ignoring design controls, but, at least when it comes to CDRH, the regulatory risks are negligible, because CDRH virtually never looks to see if design controls were followed during development...maybe after a major recall, like the currently ongoing Boston Scientific pacemaker recall, which has been officially attributed to a design failure.

I'm inclined to think that it hasn't occurred to CDRH that it should look at design controls, but maybe it just doesn't want to. That would be understandable, because then it would have to deal with what it found. At that point, it would often become painfully clear that the only way to develop the product to per user requirements or a product development plan would be to hop into a time machine and start over. So instead, paperwork is generated that says users require the product that was developed, and that the plan was to develop it the way it was developed. (What can I say, that's "innovation" for you.)

The rest of the QSR/ISO 13485 is GMP, intended to manage the quality of product manufactured for the market. Many medical device startups, amateur and experienced, don't put GMP in place until after regulatory clearance, although the experienced may give GMP due consideration during development. The need to have GMP in place in order for CDRH to make a De novo decision is one of the points of contention around its Proposed Rule for De novos.
 
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