MMD-127    Understanding of US FDA Quality Management System Regulations 

  • Overview
  • Course Objectives
  • Course Content
  • For Whom
  • Schedule and Hours
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The medical device regulatory landscape is evolving toward global alignment. With the release of the US FDA Quality Management System Regulation (QMSR), which formally incorporates ISO 13485:2016 by reference, manufacturers now face a harmonized quality system framework that supports compliance across both U.S. and international markets.

This training provides a comprehensive understanding of ISO 13485:2016 requirements and the new US FDA QMSR (21 CFR Part 820), highlighting how these two systems are interconnected. Participants will gain insight into the key similarities, differences, transition expectations from the previous US FDA Quality System Regulation (QSR) to the new QMSR model, and best practices for inspection readiness. Through structured explanations, the course will help participants build practical knowledge on how to apply both ISO 13485:2016 and US FDA QMSR requirements effectively in their quality management systems.
On completion of this training, participants will be able to:
  • Understand the structure, purpose, and intent of ISO 13485:2016 as a quality management standard for medical devices.
  • Interpret ISO 13485:2016 requirements clause by clause.
  • Understand the key functions and roles of the US FDA in medical device regulation.
  • Overview of FD&C Act and CFR.
  • Prepare for FDA inspections and audits.
  • Understand key highlights of the new Quality Management System Regulation (QMSR).
  • Section 1: ISO 13485:2016 – Overview & Fundamentals
  • Section 2: US FDA Regulatory Framework
  • Section 3: FDA Inspection & Compliance Readiness
  • Section 4: FDA Inspection Outcomes & Regulatory Response
  • Section 5: Quality Management System Regulation (QMSR)

This course is designed for anyone who may involve in the implementation and execution of this Quality System Regulation.
This is a 2-days programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.