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.

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.