Medical Device Failure Modes (ISO 14971 Risk Analysis)
Dr. Oliver Eidel
·
ISO 14971: Medical Device Risk Management
·
Updated November 26, 2025
As always, we skipped ahead a few steps for the sake of getting something done and not getting bogged down in nitty-gritty details. Now, let's catch up on what we've missed: Our fancy ISO 14971 - compliant risk analysis of our medical device also needs to include failure modes, so that's what we'll be documenting in this video.
The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here:
https://openregulatory.com/
The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here:
https://openregulatory.com/
Keep watching
All videos
14:40
Linking Up Failure Modes and Risk Controls (Medical Device Risk Analysis)
Dr. Oliver Eidel
36 views
·
8 months ago
16:13
Risk Controls Make Your Life Easier (Medical Device Risk Management)
Dr. Oliver Eidel
33 views
·
8 months ago
15:38
Hazard-Related Use Scenarios (Risk Analysis for Medical Devices + Usability Engineering)
Dr. Oliver Eidel
35 views
·
8 months ago
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!
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!
Join the discussion. Leave a comment. Guest comments are welcome — add your email to get reply notifications.
No comments yet. Be the first to share your thoughts.