I hope you’re having a great summer! Things have quieted down here in Berlin, besides the usual subtle chaos of manufacturers and auditors trying to find out what the MDR extension timelines mean for them.

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!

Ahh, the good old times when I had no obligations and could write articles all day long (or watch YouTube videos). I got back to doing that (the articles) and finally could fill some “content gaps” on our website. This time, about the IEC 62366, the standard for Usability in medical devices, and how you can comply with it. Check out the new 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.

The MDCG released a Q&A document on the new MDR transition period(s). It contains lots of nitty-gritty questions and answers which, in my opinion, don’t apply to most startups. Still, it’s quite useful and it’s not a long read. Also, the formatting is quite good this time, so.. credit where credit is due.

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.

Sören wrote a cool article on supplier management, one of those topics where he has way more knowledge than I do. Check it out if it’s relevant to your company!

The PRRC article on our website has become somewhat ancient and outdated - with the slow pace of regulation, you might think that’s impossible, and I was also surprised. But yeah, the article was still describing the no-longer required role of the German medical device safety officer. Sören fixed that (thanks!), check it out.

Sören wrote yet another great article on the difference between documents and records. If you’re a seasoned regulatory dude or dudess, you might think this is trivial (and you might be right), but a surprisingly high number of consulting clients regularly ask us about this, and it’s definitely worth writing about. Check out the article here.

There’s been an interesting development where the EU Advocate General wrote an opinion whether standards should be freely available, and somewhat surprisingly, she said they should be. I wrote up what happened here.

What sort of open source software can you use to set up your QMS nowadays? I had a look at your options, and they are not great. If I had to choose nowadays and didn’t have a budget for Formwork, I’d probably choose Google Drive - yeah, that’s not open source, and that’s kind of my point, because the open source solutions (e.g. git-based) all end up being worse. Check out my new article if you’re interested in open source QMS software!

A new section on other things outside of our cozy regulatory bubble.

Almost a year ago, we launched a free job board for jobs in digital health. It’s still around and has quite a few visitors nowadays, but it could use a few more job posts, so feel free to drop by if your company is hiring and post a job. Job posts are still free! :)

I wrote up my thoughts on VC funding and why I think it “will destroy your company”. Of course I’m biased and, to be fair, my article is heavily slanted towards the “contra-VC” position while some good arguments might be made pro-CV; still, not many people take this side of the VC debate, so I thought it was worthwhile writing about.

​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.