July 2023 Updates: New Usability Articles, MDCG Q&A On Transition, Open Source QMS Software
Did you know that I started OpenRegulatory as a side project in 2020 while figuring out what to do with my life? I was like “I’m just gonna dump all my regulatory knowledge on this website and then move on to fun things, like software development”. Well, that worked out well.
But the case in point is that it all started with me being kind-of-unemployed and writing articles. Even though I am employed nowadays, I did find some time to get back to writing articles, and it was tremendously fun. It’s all for your benefit, too, as all our articles are free as always. This time, I wrote about Usability and 62366 compliance, as you can see below. Enjoy!
New Usability Articles!
The IEC 62366 (Usability) Summary gives you an easy-to-read, high-level overview - read this first.
And How To Do a Summative Evaluation covers the activity which probability ends up being 90% of your usability compliance work: Actually planning and doing the summative evaluation.
MDCG Q&A On Transition Period, Class I Situation
A larger problem which we’re seeing which is not really described well in the document is about devices which are MDD class I and think they’ll be MDR class I. Those do not benefit from any transition period and would have needed a declaration of conformity in May 2021. The MDR amendment isn’t very clear in this regard, or at least it’s very hard to deduce from the legalese writing. I had hoped the Q&A document would answer this question specifically, but it doesn’t.
How To Do Supplier Management
Updated PRRC Article
Documents vs. Records
Standards Becoming Freely Available?
Open Source QMS Software
Side Notes
Digital Health Jobs
Don’t Take Venture Capital (VC) Funding?
The article sparked quite a discussion on Hacker News, with the Cloudflare CEO responding that VC funding actually worked out quite well for him and his company. Yeah.. fair point. Then again, Cloudflare is still not profitable, so.. maybe we’ll see.
On a different note: Do you need any help with your EU MDR efforts?
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Or, if you don't like talking to humans, check out our Wizard. It's a foolproof, step-by-step video course for getting your compliance done yourself.
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ISO 13485 Amendment, Templates, User Manuals

The IEC 62366 (Usability) Summary: All You Need To Know (It's Not Much)

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Dr. Oliver Eidel
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!