MDSAP Unlocked: Building the QMS You Need to Get and Stay Certified
Instructor
Martin King
Instructor
Sumatha Kondabolu
Course Overview
ISO 13485 forms the foundation of MDSAP, but passing an MDSAP audit requires more than ticking ISO boxes. Each of the five participating jurisdictions layers on additional obligations, and auditors evaluate your QMS not just process by process, but through the linkages between them. Those interconnections, combined with a nonconformity grading system that directly affects your certification timeline and a growing shift toward remote auditing, are where MDSAP readiness breaks down for even experienced quality teams.
In this session, you’ll leave with:
- A clear picture of how MDSAP relates to ISO 13485 and what the five-jurisdiction structure means for your QMS
- A working understanding of the nonconformity grading system and its practical implications for corrective action planning and certification timelines
- A concrete QMS readiness checklist spanning all major audit process areas
- Practical guidance on preparing for remote and hybrid audit scenarios
What You'll Learn?
- How MDSAP goes beyond ISO 13485 — and what each of the five participating jurisdictions adds on top of the standard baseline your QMS already covers
- How MDSAP's nonconformity grading system works in practice and what each grade level means for your certification timeline and corrective action obligations
- What a well-structured QMS actually needs to contain to pass an MDSAP audit — across management, design & development, production, measurement, and purchasing processes
- Why remote and hybrid auditing is increasingly the norm, and how to prepare your QMS infrastructure accordingly
- Quality and Regulatory Affairs leaders at medical device companies who are actively pursuing or maintaining MDSAP certification.