QMSR in Effect: Will Your Quality System Pass an FDA Inspection?

The FDA’s Quality Management System Regulation (QMSR) is now in effect, and inspectors are ready to find everything you’ve missed in an FDA inspection.

In recent years, medical device manufacturers have seen a dramatic rise in inspection observations and formal enforcement actions, with the number of quality system–related warning letters nearly doubling in the last year alone and far exceeding historical averages. And with the QMSR integrating ISO 13485, the likelihood that an FDA inspection will find gaps is even higher than before.

This webinar recording was designed to help medical device organizations understand what must be updated in their quality system now to align with QMSR and FDA inspection expectations. In this recording, you’ll learn: How FDA inspectors are likely to evaluate QMSR implementation during inspections A step-by-step checklist of key quality system elements that typically require updates under QMSR with specific focus on Corrective and Preventive Action (CAPA), process and software validation of the production system, and Design and development controls How to prioritize remediation efforts to reduce inspection risk without overwhelming your organization

This session is ideal for quality and regulatory leaders, compliance managers, and those responsible for inspection readiness who want more than a high-level overview. Attendees are encouraged to come prepared with specific questions about their quality system, recent changes, or areas of concern. We will also discuss how FDA inspections are likely to unfold under QMSR, including how inspectors may approach documentation, interviews, and objective evidence.

It is far better to find gaps in a webinar than in an FDA inspection.

About the Host

Markus Gee is a quality and regulatory leader with over 20 years of experience developing, remediating, and managing FDA- and ISO-compliant quality systems in the medical device industry. He has led major QMS remediation initiatives, supported FDA inspection readiness efforts, and helped organizations close systemic gaps in CAPA, design controls, validation, and regulatory compliance. Markus brings a practical, implementation-focused perspective that helps teams translate regulatory requirements into systems that stand up to inspection scrutiny.