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Medical Device Compliance: Cost & Duration

Dr. Oliver Eidel · Starter Course · Updated November 26, 2025
Are you a startup founder and wondering what the hell this whole "medical device compliance" thing is about? Look no further. We've worked with 100+ companies (and talked to many more!) and I've gathered all the frequently asked questions and their answers here for you.

What I cover:
  • How much does it cost?
  • How long does it take?
  • Should you purchase QMS software (eQMS Software)?

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How To Get Regulatory Work Done Fast: Hiring, eQMS Software, Consultants 15:20

How To Get Regulatory Work Done Fast: Hiring, eQMS Software, Consultants

Dr. Oliver Eidel

190 views · over 2 years ago
A

What's The Best QMS Software?

Anonymous
over 1 year ago
We're looking for QMS software and don't know which one to choose. Which one is the best QMS software?y
Accepted 1 answer

If you're a startup and don't know much about regulatory compliance yet, postpone that decision for now and learn a bit more about regulatory complian

A

Best team setup for Class I (EU) medical device QMS and technical documentation?

Anonymous · 1 comment
6 months ago
We are a small team preparing to set up our Quality Management System (QMS) and Technical Documentation for a Class I medical device in the EU, which includes a hardware component. We are considering
Accepted 1 answer

If the founders don't have much experience with QMS or regulatory compliance for medical devices, it's really important to build internal expertise in

Dr. Oliver Eidel

Dr. Oliver Eidel

I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.

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!
More about me

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