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YouTubeMedical Device Academy
What is a DHF? And do you still need one in the FDA QMSR? (Sept 26 @ 10:30 a.m. ET)
On March 1, 2016, the 2016 version of ISO 13485 was released. The new version of the Standard now requires procedures for design transfer, design changes, and design and development files to be further harmonized with US regulatory requirements. Then, on February 2, 2024, the FDA released the QMSR--which goes into effect on February 2, 2026 ...
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