Before Our Call: Frequently Asked Questions
So this is really about getting the most out of our call.
Introductions: Who Are You And What Is OpenRegulatory?
What Do You 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?
What About Your eQMS Software - Features, Demo, Pricing?
Consulting
How Do You Work With Companies?
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?
How Can We Be Fast?
- 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.
Which Notified Body Do You Recommend?
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?
What About MDR Class I Software?
- 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)
Is It Possible To “Separate The Medical Device” From Other Parts of Your Software?
On a different note: Do you need any help with your EU MDR efforts?
We've worked with 100+ companies and helped them certify their devices in weeks, not months. Talk to us now – first calls are free! Check out our services and prices here.
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.
And if you're looking for the best QMS software for lean, founder-led companies, check out Formwork. It automates your compliance, and there's even a free version for you to try out!
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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!