FDA Inspections Under QMSR: What Changes for Risk Management, CAPA, MDRs, and Design Controls

This course helps device organizations prepare for QMSR inspections by connecting risk management, CAPA, MDRs, Design Change Control, management responsibility, and supporting quality systems to FDA’s process-focused inspection approach.

FDA’s Quality Management System Regulation (QMSR) changes the framework for medical device inspections by incorporating ISO 13485:2016 into 21 CFR 820 and moving beyond the former QSIT subsystem model. The new inspection approach places greater emphasis on process-focused assessment and patient or user risk management based on ISO 14971:2019, affecting how manufacturers demonstrate control across their quality management systems.

This webinar examines the QMSR inspection approach described in FDA Inspection Manual 7382.850 and the areas manufacturers should expect to receive increased attention. The discussion addresses risk management throughout the quality system, CAPA, Medical Device Reporting, Risk Files, Design Change Control documentation, implantable-device traceability, senior management responsibility, and quality culture. Participants will also consider the relationship between QMSR and ISO 13485, application across device classifications, combination products, and the supporting systems needed to demonstrate compliance under FDA’s process-focused inspection approach..

| WHY YOU SHOULD ATTEND

Prepare for the Shift From QSIT to Process-Focused Inspections

Understand how FDA’s inspection approach changes under QMSR and Inspection Manual 7382.850, including the move away from the former QSIT subsystem model. This perspective helps teams assess inspection preparation against interconnected quality processes rather than relying on practices developed around the previous inspection structure.

Strengthen Risk-Based Evidence Across the Quality System

Develop a clearer understanding of where patient and user risk management affects inspection exposure, including CAPA, MDRs, Risk Files, Design Change Control, and supporting systems. With ISO 14971 principles extending throughout the quality system, manufacturers need consistent evidence showing how risk considerations influence their quality activities and decisions.

| AREAS COVERED

• FDA QMSR Inspection Manual 7382.850 and the new inspection approach
• Incorporation of ISO 13485:2016 into 21 CFR 820
• ISO 14971:2019 risk management across the quality system
• CAPA and Medical Device Reporting during QMSR inspections
• Risk Files and Design Change Control documentation
• Implantable-device traceability and supporting quality systems
• Senior management responsibility and quality culture
• QMSR considerations for device classifications and combination products

| WHO SHOULD ATTEND

• Senior management in Devices, Combination Products
• Quality Assurance Departments
• Regulatory Affairs Departments
• Medical Device product development teams
• Research and Development Departments
• Engineering Departments
• Production Departments
• Operations Departments
• Marketing Departments
• Consultants; others tasked with device QA, product development, manufacturing, process / product / data analysis, regulatory submission responsibilities