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Medical Devices

Singing in Harmony: Leveraging MDSAP to Synergize your QMS

Wednesday, May 6, 2026
10:45 - 11:45 WEST
Location: Pavilion 3
Learning Level: Intermediate
: Description : Recognition, reliance, and harmonisation are being discussed more frequently. These mechanisms and approaches rely on consistency and consensus on requirements for products and processes. A quality management system (QMS) is central to how most medical device organisations operate. The confirmation of ISO 13485:2016 for another five years and its central position within MDSAP make ISO 13485:2016 the foundation for medical device QMS.



This session explores shared QMS challenges across global frameworks, beginning with a collaborative discussion on common elements. Speakers will examine frequent ISO 13485:2016 and MDSAP issues observed by Auditing Organizations, Notified Bodies, and consultants, followed by insights into China's evolving QMS. The session then connects these themes to the U.S. QMSR before addressing implications for EU MDR and the future UK regulations. The panel concludes with an open Q&A to support practical application and cross regional alignment.

Agenda:

1. Common elements or challenges of quality system across key systems

2. MDSAP common issues that NB and Consultants see from different manufacturers

3. China new quality system

4. How they all tie to US QMSR?

5. EU and MDR and

6. Q&A

Learning Objectives:

  • Understand commonalities and key differences in QMS requirements in US, EU and China
  • Aware of common issues observed during QMS audits and incorporate practices to avoid similar issues in your organization
  • Able to leverage MDSAP and for other countries QMS for more synergy