Скачать или смотреть MDSAP Compliance Simplified – Avoiding Audit Pitfalls & Navigating Global Jurisdictions | Replay

In this expert-led session presented by MedTech Leading Voice and AKRA Team, regulatory professionals from TÜV SÜD and Philips take a deep dive into the Medical Device Single Audit Program (MDSAP) - demystifying its audit structure, grading model, jurisdictional reach, and most frequent compliance pitfalls.

Lawrence Yeh (Senior Consultant, AKRA Team) moderates a high-impact discussion with Matteo D’Angelo (TÜV SÜD Lead Auditor) and Sean Gibbons (Regulatory Affairs Manager, Philips), as they share perspectives from both the auditor and manufacturer sides of MDSAP implementation. From scope and structure to risk management and AI-readiness, this session offers concrete takeaways for teams navigating complex multi-jurisdictional audits.

If you’re managing quality, regulatory, or software-based submissions, this webinar helps you avoid costly oversights—especially for companies selling in Canada, U.S., Japan, Brazil, or Australia.

Chapters:
(00:00) – Welcome & Speaker Intros
(01:43) – What Is MDSAP? Program History & Purpose
(04:45) – Jurisdictions & Regulatory Framework
(07:30) – Audit Scope, Audit Cycle & Key Stakeholders
(11:08) – Audit Process: Stages, Structure, and Risks
(18:50) – MDSAP Grading System Explained
(25:10) – Panel: Top 3 Audit Pitfalls & Root Causes
(29:53) – How Companies Misunderstand MDSAP
(32:52) – What Would You Change About MDSAP?
(35:30) – Strategic Benefits & Audit Planning
(39:00) – Training, Resourcing & Cultural Shifts
(46:00) – Preparing for AI/ML, Cloud & SAMD Oversight
(49:00) – Panel: Q&A – Submissions, Jurisdiction Scope, Tools