Hey there! This article contains our most frequently asked questions. I typically send this around when scheduling calls so that people pre-read it beforehand. This makes everyone’s lives much better: You gain much more time for asking your specific regulatory questions, essentially getting some free consulting from me, and I don’t go crazy because I don’t have to answer the same questions over and over again :)
So this is really about getting the most out of our call.
Introductions: Who Are You And What Is OpenRegulatory?
Check out my about me page.
What Do You Offer?
Here’s what we offer:
- eQMS software (Formwork) for making your regulatory documentation more efficient by automating a lot of things.
- The Wizard, a step-by-step video course for creating your documentation yourself, startups love it.
- Consulting if you’d like us to help you get your medical device certification done from scratch by doing some project management, guiding you through the process by reviewing your documents.
- Other, smaller services like providing your so-called MDR Person Responsible for Regulatory Compliance (PRRC), GDPR Data Privacy Officer (DPO), conducting internal audits, etc.
eQMS Software
What Regulatory Software Do You Recommend?
We recommend our own, Formwork, because it’s free in its Community Edition (easy to get started) and it’s not shady, like many products of our competitors: Our pricing is transparent, we offer free trials, we don’t lock in your data and you can export it any time.
What About Your eQMS Software - Features, Demo, Pricing?
Check out the Formwork page. It also includes our (transparent) pricing and available startup discounts.
Consulting
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:
- Your internal person watches our videos - our videos are super-concrete because they show me filling out example documentation.
- You create drafts, based on our videos and free templates.
- You send us those drafts for review. We send you our feedback and also discuss open questions in weekly calls.
- When all documents are done, you’re done!
What Are Your Consulting Prices?
Check out the Headstart page.
How Can We Be Fast?
Your regulatory speed is determined by these factors:
- Speed improvement of 8-10x: Use minimalistic templates - in other words, use our templates, because they are free, minimalistic and many of them have already gone through audits.
- Speed improvement of 2-3x: Use eQMS software like Formwork.
Yes, I’m openly saying that eQMS software gives you less of an efficiency gain than using minimalistic templates :)
Which Notified Body Do You Recommend?
Subjective opinion: In the past, we recommended BerlinCert (based in Berlin, you might have guessed) but, in the meantime, we’ve made some weird experiences with them. Now they’re just as “average” (read: disorganized) as all other notified bodies. So, right now, in our opinion, all notifeid bodies are equally bad. If you’d like to make an informed decision yourself, 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.
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-50k€.
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. To make that gray area even more shady, we’ve observed that MDR class I software has only been brought to market in certain states in Germany; in other words, some state authorities likely don’t accept software as being MDR class I, while other are more tolerant. Your chances seem to be best in Hamburg and Bavaria. Check out our article on class I software with real-world examples.
Is It Possible To “Separate The Medical Device” From Other Parts of Your Software?
Yes, that’s possible and it might make sense, in some (very limited) cases. This is not necessarily determined by how well you implement it but rather by how well your auditor understands software and what their opinion on this approach is. Some auditors think it’s impossible while others think it makes sense (yep).