Agency IQ

JUNE 16, 2023

An update on the Medical Device Quality Management System Regulation : In February 2022, the FDA proposed a new rule which would effectively transition the agency away from its longstanding Quality System Regulation (QSR) in favor of the ISO 13485:2016 standard. Read our analysis of that rule here and here. ]

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Agency IQ

OCTOBER 27, 2023

December 2023 Medical Devices; Quality System Regulation Amendments (Final Rule) FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016.

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FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

December 2023 Medical Devices; Quality System Regulation Amendments (Final Rule) FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016.

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FDA Science Regulations Production 40