Module 16 2022

05/09/2022

Risk

Benefit

 B-R required for  Risk Management

 Trending  Technical

documentation

 Post-market surveillance plan  Investigator brochure  Clinical evaluation  PSUR  Vigilance

The Organisation for Professionals in Regulatory Affairs

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Risk

Benefit

Example Vaginal Mesh 2000  Considered a great solution for pelvic organ prolapse.

The Organisation for Professionals in Regulatory Affairs

44