The Regulatory Affairs Stocking Filler: 3 Tasks to Finish Before the Year Ends

The Regulatory Affairs Stocking Filler: 3 Tasks to Finish Before the Year Ends

Your main QMS audit findings might be closed, but what about the small administrative tasks that lead to big audit headaches in 2026?

Before you clock off for the holidays, make sure these three 'stocking fillers' are checked off your list:

1. Archiving Audit: Under MDR/IVDR, records like the Declaration of Conformity and Technical Documentation must be archived for a minimum of 10 years (or 15 for implantable devices). Is your document control system ready for 2026? Don't wait until the new year to move old files to long-term storage.

2. Training Log Refresh: Internal/External auditors always check the training matrix for the current year. Are all team members' ISO 13485 (2016) or SaMD guidance training logs fully updated and signed off for 2025? A missing signature is an easy finding.

3. Supplier Agreement Review: Have you performed your annual or biennial review of your critical supplier contracts? The MDR requires your Quality Agreements (QAs) to explicitly define regulatory roles (including vigilance reporting). Now is the time to ping those suppliers for a Q1 2026 review meeting.

Small effort now, massive risk mitigation later. Give yourself the gift of a clean QMS start to the new year!

Wishing everyone a peaceful and compliant holiday season. See you in 2026!

Which one of these are you tackling first today?

#MedicalDevices #Compliance #RegulatoryAffairs #ISO13485 #MedTech #HappyHolidays