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The FDA’s transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks the most significant update to 21 CFR Part 820 in nearly two decades. But for medical device manufacturers, this is more than just a regulatory rewrite—it is a shift toward global harmonization that requires immediate strategic action.
In this episode of Life Science Solutions, host Chris Adkins sits down with David Dlugo, Senior Director of Quality at Kymanox, to unpack the practical realities of the QMSR rollout. With over 30 years of experience in quality systems and design controls, David explains why "being ISO 1345 certified" isn't a free pass for compliance and how to turn this regulatory hurdle into a long-term business advantage.
Topics Include:
- The "Why" Behind QMSR: Understanding the FDA's push to harmonize with ISO 1345:2016 and what it means for global market access.
- Risk Management Evolution: Moving beyond product risk (ISO 14971) to apply risk-based decision-making across the entire quality system, from CAPAs to training.
- The Certification Myth: Why your existing ISO 1345 certificate won't stop the FDA from auditing your facility.
- Supplier Controls: How to update supplier files to be "living documents" that satisfy the new monitoring requirements.
- A 5-Step Implementation Roadmap: A proven strategy to assess gaps, remediate SOPs, and ensure your team is ready before the deadline.
Whether you are a VP of Quality or a Regulatory Affairs specialist, this conversation offers a clear, science-forward path to navigating the new landscape of medtech compliance.
📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina.
