FDA QMSR Compliance: Integrating Risk Management Across Your Quality System

Presenter: J. Lawrence Stevens, BA, RAC

Date: Thursday, December 3, 2026

Time: 1 pm ET | 12 pm CT | 11 am MT | 10 am PT

Duration: 60 minutes

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Course Description

FDA has recently revised their regulations for establishing quality systems for medical devices. The new regulation is termed the Quality Management System Regulation (QMSR). The FDA has a new inspection process that aligns with the requirements of the (QMSR).

One of the major changes in the QMSR relates to integrating risk assessment in all of the quality systems. Initially FDA said that the most common 483 item is inadequate risk management.

We will explain how to assess risk in each quality procedure and document related risk management activities. And how to document risk management actions.

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Learning Outcomes

• Risk management as a daily activity
• Understand QMSR
• How to explain to your company why risk management is required
• First steps to take
• Assessing risk for each quality procedure
• How to document compliant risk management
• How to assume FDA will be content with your risk management activities

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Areas Covered in the Session

• Risk management in your life
• Why did FDA integrate risk management into the QMSR
• What does FDA expect relative to Management Responsibility
• How to demonstrate the value of Risk Management to the overall company success
• How to begin to establish a compliant risk management effort in the quality system
• Why is training for responsible employees necessary and how to train them
• How to document risk management efforts
• How to assess risk management progress over time
• Interactive Live Q&A Session

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Recommended Participants

• Vice President of RA/QA
• RA/QA Directors
• Quality Auditors
• VP of R&D
• Quality Supervisors
• Attorneys who specialize in FDA related cases
• VP of Manufacturing
• Training Directors
• FDA Consultants

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About the Presenter  

Mr. Stevens has a unique background of FDA and Industry experience. He has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices.

From 1989 to 1993, he served as the Industry Representative on the FDA Circulatory Systems Panel, which reviewed over 30 PMA clinical studies for cardiovascular devices. He currently serves as an expert witness for cases involving FDA regulation compliance for medical devices. He regularly performs webinars regarding FDA and issues regarding clinical studies and medical devices. Finally, he is a seasoned educator/speaker with over 150 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. He routinely serves as an Expert Witness in cases involving FDA regulation of medical devices.

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