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US Regulatory Roundup, June 2022: Digital Health; Draft QMSR Stakeholder Comments; Medtech Cybersecurity, Medtech Insight

Monday, July 4, 2022

In a roundup of the top Medtech Insight stories from June, the two-part article series analyzing stakeholder comments on the US Food and Drug Administration’s (FDA’s) proposed change from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) landed in the No. 2 and No. 4 slots.

Discussing the proposed QMSR, partner Dennis Gucciardo said, “I think FDA’s presumption is that there will be new revisions to the standard, but they will not be so dramatic such that it's going to cause for the solution that this is supposedly addressing, which is that ISO 13485 and the QSR are not structured similarly.”

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