QMSRQuality Systems
NewsWhite PaperQuality Management System Regulation

QMSR Compliance Deadline: February 2, 2026

Medicept
by Medicept
1 min read
November 24, 2025

The FDA is implementing the new Quality Management System Regulation (QMSR), aligning requirements with ISO 13485 while introducing additional FDA-specific expectations for risk-based processes, documentation, and management accountability. Manufacturers will face deeper inspection focus, increased supplier oversight requirements, and a stronger emphasis on risk-based decision-making across every quality system process. Those beginning preparations now will be better positioned for QMSR readiness ahead of the February 2026 compliance deadline.

Complete the form below for the full article PDF
Previous story
← Risk Management Series – Part 5: Assigning Harms and Severity
FDA Proposed Quality Management System Regulation (QMSR): Expert Analysis – Part 1: Understanding Definitions White Paper Download
FDA proposed quality management system regulation (QMSR) expert analysis part 1
White Paper

FDA Proposed Quality Management System Regulation (QMSR): Expert Analysis – Part 1: Understanding Definitions White Paper Download

March 2, 2022 1 min read
White Paper – Proposed QMSR Expert Analysis (Part 2)
FDA building
White Paper

White Paper – Proposed QMSR Expert Analysis (Part 2)

May 17, 2022 1 min read
FDA Proposed Quality Management System Regulation (QMSR): Expert Analysis – Part 2: Understanding Proposed 21 CFR 820.35 – Records White Paper Download
FDA proposed quality management system regulation (QMSR) expert analysis part 2
White Paper

FDA Proposed Quality Management System Regulation (QMSR): Expert Analysis – Part 2: Understanding Proposed 21 CFR 820.35 – Records White Paper Download

May 17, 2022 1 min read

Patients Are Waiting.

Every submission, study, inspection, and commercialization decision moves a patient closer to the technology they're waiting for. Partner with Medicept to navigate every milestone with clarity, continuity, and confidence.

Talk to an Expert