Module 14: Design Development and Certification of Medical Devices

17/11/2023

Design and Development Planning

21 CFR 820.30( b )

(b) Each manufacturer shall establish …. plans that describe …. activities and define responsibility ….. groups that…. input to the design and development process. The plans shall be reviewed , updated , and approved …

The Organisation for Professionals in Regulatory Affairs

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Design and Development Planning

The Organisation for Professionals in Regulatory Affairs

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