ISO 13485: Basics and How to Get Started (QMS for Medical Devices) | Process Street | Compliance Operations Platform
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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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📣 Our Ireland Medical Device Delivering Office can help ensure that your medical device quality management system (QMS) meets ISO 13485 certification requirements. ✅ ISO 13485 is a minimum requirement for medical device manufacturers and at the core of numerous international market access programs, such as MDSAP, CE and UKCA marks. We can help your journey to ISO 13485 compliance, assuring you meet the requirements for: 👍 Management responsibility 👨‍🏫 Resource management 📚 Product realizati
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