Urgent Reminder!

The FDA deadline for the change from Medical Device QSR to the new QMSR is fast approaching -  February 02, 2026!  FDA CGMP Compliance Inspections are currently being conducted to the old QSR/QSIT (old 21 CFR 820) up to February 02, 2026, but after that date will be conducted to the new QMSR - the new 820, Subparts A and B, ISO 13485 in its entirety, and Clause 3 of ISO 9000.

This requires that a company's Quality Manual, QMS SOPs, and training be updated to the new QMSR and be completed with all QMS systems ready to go live on February 02, 2026.

We are rewriting QMs and SOPs for clients, to conform to these new requirements and would be happy to assist your company in doing so.

- JEL, jel@jelincoln.com