This episode unpacks the FDA's new Quality Management System Regulation (QMSR), a landmark change that harmonizes U.S. medical device regulations with the international standard ISO 13485:2016. We cover the specifics of the final rule issued on February 2, 2024, the critical transition timeline ending on February 2, 2026, and the key differences manufacturers must address. Learn about the new requirements for records, labeling, packaging, and how the QMSR will fundamentally change FDA inspections and auditing practices.

Key Questions:

• What is the FDA's new Quality Management System Regulation (QMSR)?

• How does the new QMSR harmonize U.S. regulations with the global ISO 13485 standard?

• What is the final compliance date for transitioning from the old QSR to the new QMSR?

• Which specific requirements has the FDA added on top of the ISO 13485 framework?

• How will the new rule change FDA inspections and access to internal audit records?

• What happens to familiar terms like DHF, DMR, and DHR under the new regulation?

• What are the key steps for a medical device manufacturer to ensure compliance by the 2026 deadline?

• Why are labeling and packaging controls a specific area of focus in the new QMSR?

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