FDA QMSR: QSR, ISO 13485 & Harmonization Explained
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FDA QMSR: QSR, ISO 13485 & Harmonization Explained
Explaining the QMSR (quality management system regulation) Final Rule by FDA to harmonize its quality system regulation (QSR) with ISO 13485:2016.
Aug 15, 2024
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Our Design Control course covers requirements under FDA Quality System Regulation, ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). 📅 When: Three full days (9:00am–6:00pm EST) February 11-13, 2026 🎓 With: Experts from industry and the FDA who take part in the entire course You’ll learn how to: Check if your design control system meets FDA and ISO requirements Spot gaps or issues in your process Make the improvements needed to stay compliant 👉 Learn more and register here:
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