We’re Collaborating With BerlinCert, a Software-Focused Notified Body

We’ve started a collaboration with BerlinCert, a Notified Body which focuses on Software as a Medical Device (SaMD).

Why would we do that?

Martin Tettke, their Head of Certification, reached out to me a while ago and we had a meeting. I guess the funny thing there was that we had already been implicitly working together for a while, because quite a few of our consulting and Formwork customers were getting certified at BerlinCert. We just hadn’t met before.

Given that I often don’t get along that well with regulatory people (especially auditors), we got along surprisingly well! One of the reasons for that was that Mr. Tettke actually has a rather technical background (he studied engineering) and tinkers with software and servers quite a bit, too. That makes him one of those very (very!) few auditors who have actual, real-world software experience.

And no, they didn’t pay me to write that, that’s my actual opinion.

Is this a blanket endorsement of BerlinCert? Nope. When choosing your Notified Body, always speak to startups who’ve gone through the process there and make your own decision.

Instead of an endorsement, this is a rather boring announcement that, well, we’re collaborating with BerlinCert (thanks for reading this far, by the way). So what will we be collaborating on?

We’ll work on making it easier for Healthcare startups to hand in their documentation. Specifically, we’ll work on data formats for submitting technical documentation – as BerlinCert is a Notified Body, they don’t provide consulting, so they won’t really tell us what should be in each template (among other things). But that does open up other opportunities, like collaborating on interesting file formats which make submissions.. suck less. For example submitting an interactive risk table as a HTML file, that would be cool.

One problem is that PDFs suck, especially those sort of PDFs exported from Jira (my words, not those of Mr. Tettke). Maybe we could start there, and maybe, down the road, you’ll be able to use Formwork to submit to BerlinCert.. but, for now, let’s start with the crappy PDFs.

On a slighty different note: You want to get your medical software certified under MDR but don’t know where to start? No worries! That’s why we built the Wizard. It’s a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you’re looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We’ve built Formwork, and it even has a free version!

If you’re looking for human help, did you know that we also provide consulting? We’re a small company, so we can’t take on everyone – but maybe we have time for your project? We guide startups from start to finish in their medical device compliance.

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