Quick Tip: Start getting ready for QMSR compliance before it is too late.
QMSR goes into effect in February 2026. FDA might apply some discretion but compliance will be expected the minute after it goes into effect. Develop a solid transition plan before its is too late.
Listen to the full podcast here 👇
LTR 63: A lawyer's perspective on the QMSR transition
“Don’t be comfortable saying, ‘Oh I follow the ISO (13485) to the letter’; it doesn’t matter. You have to comply with 21 CFR 820.”