FDA QSR to QMSR Transition Training
Regulation
Quality Assurance
Audits
Starts at: 09:00
Duration: 1 Meeting
Language: English
QMSR Transition Training: Adapting to the New FDA Regulation
This training provides a comprehensive overview of the U.S. FDA’s new Quality Management System Regulation (QMSR), which replaces the existing Quality System Regulation (21 CFR Part 820) and incorporates ISO 13485:2016 by reference. The course explains the regulatory background, structure, and intent behind the QMSR, including its alignment with international quality standards.
Participants will learn how the regulation impacts core QMS elements such as design controls, supplier management, and risk-based processes. The course will highlight both harmonized ISO clauses and unique FDA requirements.
By the end of the course, attendees will be equipped with the knowledge and tools to assess their current QMS, identify required updates, and plan a smooth and compliant transition to QMSR by the 2026 deadline.
How will I benefit?
• Understand the full scope and implications of the QMSR final rule
• Learn to conduct a gap analysis between QSR, ISO 13485, and QMSR
• Gain practical tools for updating SOPs, forms, and quality documentation
• Receive guidance on integrating risk management throughout your QMS
• Prepare for FDA inspections under the QMSR framework
• Reduce duplicate regulatory efforts across markets
Who Should Attend
Professionals working in the medical device industry including Quality, Regulatory,R&D, Manufacturing, Engineering, and Clinical teams.
About Sivan Luder, PhD
Dr. Sivan Luder is a Regulatory, Clinical, and Quality Expert with a PhD in Molecular Biology and over 10 years of experience across various industries, with a strong focus on the medical device sector. Possesses a deep scientific background and extensive experience in leading the development and implementation of medical devices from concept to commercialization, managing regulatory projects, and preparing...
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Basic Requirements
• No prior knowledge is required. However, familiarity with ISO 13485 and ISO 14971 is a significant advantage, as it will enhance comprehension and engagement with the training content.
• For those unfamiliar with these standards, follow-up learning can be completed afterward to reinforce understanding and fully benefit from the QMSR transition training. (Ask us about completion training sessions)