Agile Development For Medical Device Software: Is It Possible?
Dr. Oliver Eidel
·
Software as a Medical Device
·
Updated May 19, 2024
This is the million-dollar question, or the Holy Grail of medical device compliance: Can you do agile development which magically generates all the necessary compliance documentation for your audits? I'll walk you through what's needed for passing audits, and based on a typical agile development process (ours!), we can take a look at whether it's possible.
Keep watching
All videos
24:36
Software Test Documentation For IEC 62304 Compliance (Medical Device Software)
Dr. Oliver Eidel
626 views
·
over 1 year ago
12:48
Auto-Generate Audit Spreadsheets For Requirements Management
Dr. Oliver Eidel
132 views
·
over 2 years ago
12:37
Clinical Evaluation: The Clinical Evaluation Report (CER)
Dr. Oliver Eidel
59 views
·
6 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.