Module 16 2024

10/17/2024

Is there any other Guidance? ISO/TR 20416:2020

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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Is there any other Guidance? ISO/TR 20416:2020

The intent of this guidance

document is to provide guidance

to manufacturers who are planning and executing their post-market surveillance activities” and should be read in conjunction with ISO 13485 and

ISO 14971. (ISO/ TR 20416:2020)

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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60

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