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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Are you ready for the new FDA Quality Management System Regulation (QMSR)? We’re offering our flagship QMSR course, Navigating and Implementing the Requirements: March 16-20, 9:00am–6:00pm EST (final day ends at 1:00pm). We'll help you apply the FDA’s amended 21 CFR 820 and ISO 13485:2016 and give you tools to achieve full compliance before next year. You’ll learn to: ⚙️ Implement a Risk-Based QMS 📘 Align with ISO 13485:2016 🧭Ensure 2026 Compliance 💡 Apply QMSR in Practice Developed by FDA-le
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#medicaldevices #quality #regulatoryaffairs #fda #iso13485 #designcontrol #aamitraining | AAMI
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#medicaldevices #quality #regulatoryaffairs #fda #iso13485 #designcontrol #aamitraining | AAMI
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