Harmonization in Practice:

What RA/QA Teams Must Do Before 2026

October 29, 2025 | Hosted by Grand Avenue Software

As the FDA moves toward full implementation of the Quality Management System Regulation (QMSR) in February 2026, RA/QA teams are under pressure to understand what’s changing, what’s staying the same, and how to prepare their systems accordingly.

In this webinar, our expert panel breaks down the transition from the long-standing QSR (21 CFR Part 820) to the newly harmonized QMSR aligned with ISO 13485:2016, offering clarity, practical steps, and real-world considerations for organizations of all sizes.

Featured Panelists

  • Kristin Mortenson, President and Founder at Nirin Development, brings 35+ years of startup-focused experience across product development, quality, and regulatory strategy. Having worked extensively with both QSR and ISO 13485, she helps teams achieve compliance without disrupting development.
  • Laurie Lewandowski, Consultant at Honkanen Consulting, with over 30 years of experience across Class I–III devices, Laurie has guided RA/QA teams through FDA inspections, ISO audits, and multiple acquisitions. She brings a practical, detail-driven approach to aligning procedures, terminology, and documentation with QMSR.
  • Steve Cohen, VP of Business Operations at Grand Avenue Software, leads implementation and customer success at Grand Avenue Software. He moderates the discussion and brings a pragmatic view of how regulatory changes translate into everyday QMS workflows for medtech teams.

  • “Harmonization doesn’t mean identity.
    ISO 13485 and QMSR are aligned, but they are not the same.”

  • “Risk is no longer just about design validation.
    Under QMSR, it runs through the entire quality system.” 

  • “You don’t have to panic about old terminology. What matters is that you understand the intent behind the new terms.” 

  • “FDA’s priority is that you understand the rule. If you can show you’ve read it and built a plan, you’re in good shape.” 

Key Takeaways from the Panel

Understand the Shift from QSR to QMSR

  • QMSR keeps 21 CFR Part 820 but replaces most detailed text with incorporation by reference to ISO 13485:2016.
  • QSR subsections you may be familiar with (.30, .40, etc.) are removed under QMSR; the new rule centers on just six sections (.1, .3, .7, .10, .35, .45), with the remainder incorporated by reference to ISO 13485:2016.
  • Harmonization doesn’t mean identical: FDA still adds requirements specific to U.S. regulation and enforcement.

Navigate New Terminology Without Derailing Operations

  • Legacy terms like DMR, DHR, DHF are being replaced by ISO language such as Medical Device File, Design & Development File, and Batch/Lot Records—but you don’t have to change everything overnight.
  • FDA’s priority is that you understand the new terms and meet the intent; you can transition terminology via a quality plan or low-risk CAPA instead of a “big bang” change.
  • Train teams to recognize both old and new terms so they can speak the same language as FDA investigators.

Make Risk Management Central to Your QMS

  • Validation—it threads through supplier control, CAPA, complaints, and overall QMS decision-making.
  • ISO 14971-style thinking should inform not only product development but also how you prioritize improvements and allocate resources.
  • RA/QA leaders should expect more scrutiny on how risk is considered in quality planning, not just in the risk file.

Plan and Document a Thoughtful Gap Analysis

  • A structured gap analysis against ISO 13485 plus the new QMSR sections is strongly recommended, even if you’re already ISO-certified.
  • Use a quality plan or CAPA to document how you’ll update procedures, terminology, and references over time.
  • Focus early on: updated references, terminology, complaint handling, records, and labeling/packaging requirements.

Know What Changes for ISO 13485–Certified Companies

  • ISO 13485 certification covers most of the requirements, with QMSR adding a few FDA-specific expectations related to complaints, records, labeling, and terminology.
  • You do not need a separate ISO 13485 certificate to comply with QMSR, but alignment with the standard is now baked into U.S. regulation.
  • For companies eyeing acquisition or global distribution, ISO certification may still be a strategic advantage.

Prepare for New Expectations in FDA Inspections

  • FDA investigators are being trained on QMSR; over time, they will expect you to be able to talk in QMSR/ISO 13485 terms.
  • Internal audits, supplier audits, and management reviews may now be reviewable by FDA. Plan for this and ensure those records support your story.
  • Pre-2026 audits conducted under QSR don’t need to be rewritten, but you should be ready to explain your transition plan and current status.

Ready to Strengthen Your QMS?

Grand Avenue Software helps MedTech teams modernize documentation, training, audits, complaints, and more—aligned with ISO 13485 and the new QMSR.

Talk to our team to learn how Grand Avenue can help you stay audit-ready, investor-ready, and market-ready. 

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