Impact of the FDA QMSR on Medical Device Manufacturers

For Manufacturers supplying product to the U.S. market that do not align with the requirements of ISO 13485, and in contrast for manufacturers supplying product to the U.S. that either self-declare to ISO 13485 or are certified to ISO 13485, there will be a notable difference in how they establish, implement and maintain their QMS from February 2nd, 2026.

Join us on Thursday, September 12th 2024, from 10am CST, where Comply Guru’s Michelle Keane will discuss the new FDA QMSR and its impact on manufacturers of product to the U.S. in relation to the change in the structure, what the “reserved” parts will mean for manufacturers, where the FDA considers that ISO 13485 does not go far enough and from an FDA assessment perspective what changes manufacturers can expect regarding the types of records that the FDA can now sample as part of the QMSR inspection.

This Webinar will discuss key topics including:

• Outline of the Structure of the FDA QMSR
• The Reserved Subparts of the QSR
• Substantive Parts vs Additional Requirements
• Changes to Scope of the FDA Assessment under the QMSR
• Q&A

Register for FREE to gain access to this Webinar (Live Event).