QMSR Implementation Masterclass
FDA’s shift from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) aligns with ISO 13485, but what does that mean for your compliance strategy?
The FDA has amended this regulation to align more closely with the international consensus standard for devices by converging with the Quality Management System (QMS) requirements of ISO 13485:2016. This course aligns regulatory understanding to the framework for the USA with that used by other global regulatory authorities to promote consistency in the regulation of devices and provide a timelier introduction of safe, effective, high-quality devices to patients
At a Glance
- Target Audience: Designed for quality and regulatory professionals in the medical device industry, this course supports both individuals and organizations seeking practical training in quality management systems, QMSR compliance, and operational excellence.
- Total Length of Course: 3 hours
- RAC Points: 3
- Learning Level: Intermediate
- This course was developed by Michelle Lott and Tianna Benson from LeanRAQA
Learning Objectives
Upon completion of this course, participants should be able to:
Lesson Titles
Lesson 1: QMSR Fundamentals
Lesson 2: Decoding QMSR Expectations
Lesson 3: QSR vs. ISO 13485 - Comparing Key Process Requirements
Lesson 4: QMSR vs. ISO 13485 - Key Differences and Definition Hierarchy
Lesson 5: QMSR Transition
Lesson 6: Keys to Successful QMSR Transition and Ongoing Compliance
This course is also included in:
