With the FDA’s Quality Management System Regulation effective February 2, 2026, many manufacturers are reexamining how U.S. regulatory requirements are reflected in their quality systems and how those requirements are assessed during an MDSAP audit.
At the same time, the MDSAP Audit Approach, MDSAP AU P0002, was updated with a version date of February 2, 2026. This update reflects alignment with the current regulatory landscape and revised references used during audits.
This webinar explains what these updates mean in practice, where audit teams are focusing their attention, and how to avoid repeat nonconformities. Key areas of focus include management oversight, risk based process controls, CAPA effectiveness, supplier controls, and post market feedback loops.
Objective
Explain what the February 2, 2026 QMSR effective date means for device manufacturers and how it connects to an MDSAP audit
Identify changes in the updated February 2, 2026 version of the MDSAP Audit Approach and where organizations should update internal audit checklists, mappings, and evidence packages
Recognize common 2026 audit focus areas, including documentation quality, objective evidence, process based auditing expectations, CAPA effectiveness, supplier oversight, and management review linkages
Apply a practical readiness plan that includes gap checks, evidence organization, interview preparation, and audit week strategies to reduce disruption and shorten remediation cycles
Agenda
- The MDSAP 2026 update and changes to the Audit Approach
- Where audit teams are focusing
- Avoiding repeat findings through structured readiness
- Staying current between audits
- Live Q and A
Target Audience
This webinar is aimed at:
- Quality, regulatory, and compliance leaders at medical device manufacturers across all device classes
- MDSAP management representatives and audit hosts
- CAPA, supplier quality, and operations leaders responsible for process performance and evidence
- Internal auditors and teams updating audit checklists and mappings due to 2026 changes
Language: English
Cost: No charge
Cannot make a live session? Register now and receive a complimentary recording after the live event.
Speakers
Balázs Bozsik
Technical Director, Medical Audit, SGS
Balázs Bozsik is the Technical Director for the Medical Audit team at SGS North America. After graduating as an integrated mechanical engineer from the Budapest University of Technology and Economics, he gained experience in manufacturing technology and design engineering in medical imaging, automotive, and consumer lighting industries. Prior to joining SGS, he spent more than 14 years with another TIC organization, serving as Global MDSAP Program Manager, certification officer, product specialist for active medical devices and medical software, and medical auditor across major certification schemes.
Daniel Fisher
Regional Sales Manager, Medical Devices, SGS North America
Daniel Fisher is the Regional Sales Manager for Medical Devices in the western United States. He is an electrical engineer and has been with SGS for four years. During his tenure, Daniel has worked closely with hundreds of medical device and IVD manufacturers to achieve quality and regulatory certifications.
For further information, please contact:
Dominic James
Marketing Assistant
t: +1-201-508-3000