Episode 11: FDA QMSR Readiness: Training, Risk, and Audit Evidence That Holds Up

Episode 11: QMSR Enforcement Is Live: What Changes in FDA Inspections

As of February 2, 2026, the FDA has officially begun enforcing the Quality Management System Regulation (QMSR), aligning 21 CFR Part 820 with ISO 13485 and fundamentally changing how medical device manufacturers are evaluated during inspections.

In this QT9 Q-Cast episode, Christian Reyes sits down with Michelle Keane, QA/RA Director at ComplyGuru, to explain what this shift means in practice. QMSR is not a simple renumbering of QSR clauses. It introduces a risk-based inspection model where investigators follow signals across interconnected processes instead of reviewing documentation in isolation.

FDA inspectors are expected to move faster and dig deeper—tracking complaint trends into CAPA, evaluating how management review decisions address risk, and assessing whether leadership actions make sense when data indicates exposure. Documentation still matters, but only as evidence of effective risk-based decision-making.

The conversation highlights several critical realities:

• ISO 13485 certification alone does not ensure QMSR compliance
• FDA-retained requirements such as complaint handling, CAPA, MDR, labeling, traceability, and UDI remain enforcement drivers
• Risk management now extends beyond design controls into audits, management review, and operational processes
• Leadership engagement is central to successful inspection outcomes
• Siloed spreadsheets and disconnected systems undermine traceability

Organizations that approach QMSR as a modernization opportunity—strengthening process integration, validating their eQMS, and improving real-time visibility—will be positioned for success. Those treating it as a documentation update will struggle to demonstrate control.

For medical device manufacturers operating in regulated industries, this episode clarifies how the inspection mindset changes first under QMSR—and why integrated, cloud-based quality systems are no longer optional for maintaining compliance confidence.

Michelle Keane
QA/RA Director, ComplyGuru
Lead Auditor & MDR Assessor

Links & Resources

• FDA Quality Management System Regulation (QMSR): https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr
• ComplyGuru: https://complyguru.com/
• ComplyGuru FDA QMSR Transition Training: https://complyguru.com/en-us/training/fda-qmsr-transition-course/

Referenced Standards & Regulations

• FDA 21 CFR Part 820 (QMSR)
• ISO 13485
• ISO 14971
• FDA 21 CFR Part 803 (MDR)
• FDA 21 CFR Part 806 (Corrections & Removals)
• FDA 21 CFR Parts 801 & 830 (UDI)
• MD-SAP