MMD-117    Integrating ISO 13485:2016 with 21 CFR Part 8120 - Navigating the
​                      FDA's Quality Management System Regulation (QMSR)

• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

<

>

For medical device manufacturers, aligning a Quality Management System with both ISO 13485:2016 and the U.S. FDA’s 21 CFR Part 820 is essential to ensure regulatory compliance ntegrating both standards not only enhances compliance but also strengthens risk management, process control, and overall product safety throughout the lifecycle.

Although ISO 13485:2016 and 21 CFR Part 820 share similar quality principles, they differ in structure and regulatory emphasis. Successfully integrating these standards can eliminate redundant processes, streamline audits, and improve documentation. For organizations serving both global and U.S. markets, this alignment helps ensure consistent quality while meeting diverse regulatory expectations—supporting operational efficiency and market expansion.
This intensive 2-day training program is designed to support organizations in aligning their existing Quality Management Systems (QMS) with the U.S. FDA’s final rule that brings 21 CFR Part 820 into conformity with ISO 13485:2016. With this harmonization, medical device manufacturers must adopt a more globally unified approach to compliance and quality assurance.

Upon completion this programme, participants are able to:

• Understand the FDA’s Quality Management System Regulation (QMSR) and how it aligns with ISO 13485:2016.
  
• Identify key similarities and differences between the two requirements to better align their QMS processes.
  
• The program provides practical steps for closing compliance gaps and preparing documentation in accordance with risk-based thinking.
  
• Gain insights into inspection readiness under the QMSR framework and learn how to manage records and controls effectively.
  
• Explores regulatory transition timelines and the broader impact of global harmonization on medical device quality strategies.
  

• Module 1: Introduction to FDA’s Final Rule on QMSR
• Module 2: Structural Comparison ISO 13485 vs 21 CFR 820
  
• Module 3: Key Areas of Convergence and Divergence
  
• Module 4: Practical steps to close gaps in your current QMS
  
• Module 5: Risk-based Thinking, Documentation, and Record-Keeping Expectations
  
• Module 6: Preparing for FDA inspections under the QMSR framework
  
• Module 7: Regulatory transition timelines and industry readiness
  
• ​Module 8: Global harmonization and its impact on quality system strategy
  

This course is designed for :

• Quality assurance and regulatory affairs
  
• Medical device manufacturing and compliance
  
• Internal and lead auditing
  
• Quality system implementation and improvement
  
• Senior management overseeing regulatory responsibilities
  

This is a ​2 days programme.
​
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.