Thursday, 27 February 2025 | 09:45 - 10:00
FDA transition from the QS Regulation to the QMSR
Location:Amazonas 2+3 (QTICS-SAASCO Room)Track:Presentation (in Sections)
- SECTION 5: FDA workshop
Do you understand that the FDA is changing its quality system regulation (QSR) requirements that have been in place for over 2 decades and how it will affect you? It’s called the Quality Management System Regulation (QMSR) and many think it is just ISO 13485. However, there are a lot of small differences that all medical device companies selling into the US need to understand. Attend this brief presentation to learn more about how to understand what is going to happen on February 2, 2026 and how to prepare.
1 speaker
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