Transitioning to the FDA Quality Management System Regulation

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Transitioning to the FDA Quality Management System Regulation (QMSR) (Aug 2024)

Aug 27 to Aug 29, 2024


The FDA recognizes the benefits of harmonization with other regulatory authorities, and it has determined that ISO 13485:2016, the globally recognized standard for a medical device organization’s QMS, is substantially similar to the current version of 21 CFR Part 820 which became effective in 1996.

To promote consistency with its regulatory counterparts, the FDA is transitioning from the existing 1996 version of 21 CFR Part 820, the Quality Management Regulation, to the updated 21 CFR Part 820, the Quality Management System Regulation (QMSR) which will become effective on February 2, 2026.  The QMSR will incorporate by reference ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes.

The QMSR adds additional definitions and provisions to meet FDA’s statutory and regulatory framework.  Therefore, medical device manufacturers must prepare for the transition to the QMSR, even those who are currently certified to ISO 13485:2016.

This course will provide attendees with a detailed overview of the structure of the QMSR, the general and supplemental provisions, and the FDAs expectations for a corporate culture of quality and risk-based decision making throughout the quality management system.


Over the course of Six (6) hours, the program will:

  • Identify the structure and intent of the QMSR, including the incorporation by reference of ISO 13485.
  • Understand the additional definitions and provisions to meet FDA’s statutory and regulatory framework.
  • Apply the knowledge of the QMSR to planning for and establishing a compliant QMSR prior to the 2/2/2026 effectiveness date.

Who Should Attend?

Instruction is targeted to professionals directly involved in meeting both FDA and international quality system requirements or those who are ultimately responsible for compliance, including harmonization with 13485. To maximize your learning opportunity, we recommend this course for intermediate or advanced professionals that already have a basic understanding of a quality management system.

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email
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Margaret Koga Ward

Principal Engineer & Owner, Teragram LLC

Margaret Koga Ward has over 30 years of medical device experience, specializing in Product Development, Quality Management Systems, Internal and External Auditing, and Risk Management.  She is currently an Independent Consultant, a Notified Body Auditor specializing in MDSAP and ISO 13485 audits, and an AAMI University faculty member.  Her passion is helping companies achieve their quality management system and product development goals to advance their devices from concept through to commercialization within an FDA and ISO compliant quality system. 

Ms. Koga Ward has served as a consultant for the FDA to develop and present quality management training courses for multiple divisions within the FDA. 

Prior to becoming an independent consultant, she held various senior level project management, quality management system, and engineering positions leading cross functional teams throughout all phases of product development and quality system integration.  

Ms. Koga Ward served as the Project Manager responsible for the integration, development, and commercialization of a novel, invasive device.  She was also the senior consulting engineer for an Arizona based consulting firm; in this role she managed quality and product development projects for a wide range of Class I, II, and III medical devices including orthopedic, cosmetic, cardiac, ocular, and gastro-esophageal devices.  She is an established subject matter expert for FDA regulations, ISO 13485, risk management, packaging, human factors, biocompatibility, and sterilization. 

Ms. Koga Ward holds a Mechanical Engineering degree from California Polytechnic University San Luis Obispo. 

Tina Krenc

Principal Consultant, KTA Compliance Consulting

Tina is the Principal Consultant for KTA Compliance Consulting. She has over 40 years of medical device industry experience in a variety of organizations and functions including IVDs, software, hardware, combination products, and implantable medical devices. She has led employees in research and development, clinical research, operations technical support, and has over 25 years of quality assurance experience in multiple quality organizations.