MDR Classification Chaos and User Manuals
we've published some new articles about regulatory stuff and the things we do. The first one is about the not-so-helpful new MDCG 2021-24 regarding classification of medical devices: Is an Apple Watch a medical device? Are radiology AI devices always class III? What can be deemed class I according to the new guideline? Check out the article.
There's also a new case study where we helped solve regulatory problems of a class 1 MDD device for less than 2k. So efficient! The app is called BabyCare and it’s a preventive care program for pregnant women based on more than 20 years of experience and research, pretty cool. It's even reimbursed by more than 70 health insurance providers. Read more about what we did and how it went.
And if you ever wondered whether you need to force your users to read the User Manual or if you could just let them be humans and not read it, we've got you covered here.
We hope you have a great Advent season and don't get too annoyed by regulations. See you next year. Until then, Merry Christmas and a Happy New Year. Btw: We're out of office in the first week of January.
Best Christmas wishes,
OpenRegulatory
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!
ISO 13485 Amendment, Templates, User Manuals
July 2023 Updates: New Usability Articles, MDCG Q&A On Transition, Open Source QMS Software
Medical Device Classification
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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!