Note: If you came across this post randomly and haven’t scheduled a call with us, feel free to skip it and continue surfing! You can still read it if you’re interested, of course.

Hey there! Thanks for booking a call with us. Our call slots are typically limited to 30 minutes. That’s why I’ve created this post in an attempt to answer frequently asked questions first. That way, we can get those out of the way beforehand and you can get the most out of your call! :)

Introductions: Who Are You And What Is OpenRegulatory?

I’m Oliver, a medical doctor by training. I did my doctorate research in Neuroradiology and published a few papers there. That’s how I got into developing software which is the most fun activity for me, ever. I worked at Vara, a Berlin-based company developing machine learning - based breast cancer screening software. There, I developed the first version of the software, built the software team, got the medical device certification (MDD Class IIb) and built the regulatory team.

Now, I’ve founded my own company called OpenRegulatory. We noticed that other regulatory consultants don’t do a good job - not because they’re evil by nature, but often because they don’t understand software well or are simply disorganized. We try to be different: We value transparency, efficiency and modern tooling. That’s why we publish all our templates for free, host a free Slack community for 500+ people to get answers to their regulatory questions, and we offer a free QMS software called Formwork.

Our end goal is to make consultants unemployed, including us. I like to think about this like when you try to learn software development: There are so many free resources out there and you don’t need a “software development consultants” to teach you how to develop software. You teach yourself. And, one day, we hopefully have enough regulatory resources on our website so that you can teach yourself and only need our help when dealing with complicated questions. Long-term, regulatory software like Formwork will have the most leverage in increasing your efficiency.

We also like the idea that, by helping many startups enter the market who wouldn’t have made it with other consultants, we can increase the diversity of Healthcare software and thereby help bring some innovation to hospitals which are full of crappy software.

How Do You Work With Companies?

Our goal is to make companies independent of consultants as fast as possible. While other consultants might like the idea of billing hours forever, we want you to get your project done and move on with our lives. One prerequisite for that is that you have one or two people internal in your company who will take charge of your regulatory documentation effort.

The steps are:

1. Your internal person watches our videos - our videos are super-concrete because they show me filling out example documentation.
2. You create drafts, based on our videos and free templates.
3. You send us those drafts for review. We send you our feedback and also discuss open questions in weekly calls.
4. When all documents are done, you’re done!

What Are Your Prices?

We prefer fixed-price offers because they incentivize everyone the right way: We only get paid when documents get done, and you have full cost control because the final price is already determined upon project start.

These offers are usually based on multiple milestones. A milestone contains a specific set of documents, typically somewhere between 3 and 9 of them. When all documents of a milestone are done, you pay us for that milestone.

The price depends on your medical device class, your product complexity and how much of the work you want to do yourself. Let’s see some examples:

• If you have a MDR class I device and do most of the work with a product of normal complexity, the price would be around 20-30k€.
• Similarly, if your product is class IIa, it would be somewhere around 50-70k€.

What Regulatory Software Do You Recommend?

We commend our own, Formwork, because it’s free in its Community Edition and it’s the best (but we may be biased there).

Which Notified Body Do You Recommend?

These opinions are my personal opinions and therefore highly subjective and anecdotal.

I’ve heard many good stories about BerlinCert. But I’m biased because they’re also located in Berlin and seem to be popular among startups. Your case might be different. That being said, we’ve built a database of anonymous Notified Body Reviews in which lots of companies have rated their experience with their notified body, so take a look at those and make your own decision.

We’ve also updated that page with some data on their capacity, or, in other words, whether they take on new companies (like yours) and what an expected audit wait time could be.

How Much Does a Notified Body Audit Cost?

Depends on your notified body, company size and how much additional time they spend because they find problems in your documentation. You can probably estimate that at mid-five-figure sum in Euros, like 30k - 40k€.

What About MDR Class I Software?

Nobody really knows whether MDR class I software devices exist. It’s a huge gray area. That being said, we see a few viable approaches to this, based on other MDR class I devices on the market:

• Claim that you’re doing “direct therapy” of a disease while not providing information for diagnostic and therapeutic purposes (MDR rule 11);
• Claim that you’re monitoring of a disease and/or alleviation of symptoms while not providing information for diagnostic and therapeutic purposes (another take of getting around MDR rule 11);
• Fertility tracking (example in MDCG classification document, albeit rather useless)

Again, it’s a gray area. You might have a higher chance of being successful (in a regulatory sense) with a class I device if you remove certain features from it. We could work out a strategy for that during an afternoon workshop.

Is It Possible To “Separate The Medical Device” From Other Parts of Your Software?

Yes, that’s possible, but in 90% of cases it doesn’t make sense. If you ship non-medical-device software alongside your medical device software, you have to ensure that you medical device software is sufficiently isolated from the non-medical-device software.

One test for this could be whether you non-medical-device software can be used without your medical device software. Like, if your product is a mobile app and you claim that certain parts of that app are not part of the medical device, that doesn’t make sense because users can’t only use a “sub-part” of your app. They can either use all of it or nothing. It’ll also be hard to argue that those parts are isolated from one another because a crash in the non-medical-device part will crash the whole app.

Still, in some (rare) cases it’s possible and makes sense. Probably another good topic for an afternoon workshop.

Do You Offer Reduced Rates For Startups?

Kind of. We’ve mostly moved to only offering fixed-price offers. We could negotiate giving you a discount if you offer to do more of the work, i.e., drafting documents and requiring less of our time for reviewing them and doing weekly calls.