Module 16 2022

05/09/2022

Benefit / Risk

Detect and Report trends

Design and Manufacture

PMS

PMS of other devices

Clinical Evaluation

Options to improve usability, performance and safety

PSUR SSCP

Need PA / CA / FSCA

The Organisation for Professionals in Regulatory Affairs

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Public available information about similar devices

Feedback and complaints from users and

Serious incidents / PSUR’s and FSCAs

Economic operators

PMS Plan

Info from tech literature and databases

Non-serious incidence and undesired side-effects

Info from trend reporting

The Organisation for Professionals in Regulatory Affairs

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