Hungry to learn about ISO 14971 and QMSR?
Key Expectations for ISO 14971 Compliance with Implementation of QMSR
Our friend Etienne Nichols and the good people over at Greenlight Guru hosted a wonderful free webinar discussion between Christie Johnson (Prodct) and Edwin Bills (Edwin Bills Consulting, also a member of the Prodct Advisory Board) to discuss risk, ISO 14971, and QMSR.
Our favorite comments in the chat? “Now I’m hungry!” because Christie kept talking about how “delicious” it is to read ISO/TR 24971:2020 (Guidance on the application of ISO 14971). Give it a listen. You’ll know what we mean.
If you learn anything from listening, it’s these four points
You need to practice risk management to comply with QMSR
FDA tells us complying with ISO 14971 is a very good idea
Your quality system is more than your SOPs... It's behaviors and attitudes, too
Your risk management processes need to touch the whole lifecycle of your device
Quick Links
Learn More
↗ New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis (Feb 2024)
↗ The intersection of ISO 13485 and ISO 14971 under FDA QMSR (May 2023)
