The US FDA QMSR Transition - 21 CFR 820 And ISO 13485

  • Instructor : John E. Lincoln
  • Level : Intermediate
  • Study time : 93 minutes
  • Course ID: TF3650
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ABOUT THE COURSE

Are you ready for the FDA's biggest quality system shift in decades?
Do you know how ISO 13485 and ISO 14971 reshape risk and design control expectations?
Is your team clear on what stays, what changes, and what needs to be re-validated?


This course helps you cut through the QMSR complexity—giving you clear steps to stay compliant, update your QMS, and meet both FDA and ISO standards without confusion or delay.


WHAT WILL YOU GAIN
  • A detailed breakdown of QMSR expectations vs. existing 21 CFR 820 requirements
  • Insight on how risk management under ISO 14971 must now shape your QMS
  • Guidance to handle the one-year transition without disrupting operations


WHY TAKE THIS COURSE
  • Eliminate ambiguity between ISO and FDA quality expectations
  • Learn where current processes fall short of QMSR and how to fix them
  • Build team alignment before the transition window closes


KEY AREAS COVERED
  • The structure and intent of the new Quality Management System Regulation (QMSR)
  • How “incorporation by reference” pulls ISO 13485 into 21 CFR 820
  • Expanded risk management expectations tied to ISO 14971
  • Key changes to design control, traceability, and customer focus
  • Impacts on Class I, II, and III devices—plus combination products
  • Phase-in timeline and what to prioritize during the transition

Quality training, expert insights, and answers that matter. Know your Expert

JOHN E. LINCOLN

With 36+ years in FDA-regulated industries and decades guiding clients through audits, remediation, and regulatory shifts, John E. Lincoln has seen every quality system challenge from both sides. From startups to Fortune 100s, he’s helped teams bridge gaps between QSR and ISO, design smarter CAPA systems, and avoid compliance landmines. If you want clarity on QMSR, he’s the guy you want in your corner.

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