FDA published proposed changes to 21 CFR part 820 which seeks to harmonize the regulations with ISO 13485.
Public comment is due before May 24, 2022 related to the proposed changes.
Follow link below.
#gmp #fda #regulations #fda21cfrpart820 #iso13485
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Consulting in: Medical Device, Orthopedic & Spinal Devices, Product Development, Design, 3D CAD,
Engineering, Finite Element Analysis, FEA, Quality Management System, QMS, ISO 13485,
ISO 9001, FDA Compliance, FDA 21 CFR 820, Design History Files & Remediation
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