Module 5 Presentations

16/07/2024

Excercise.

• What type of study is required in the scenario that you have been given?

The Organisation for Professionals in Regulatory Affairs

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Why Medical Device CIs are different

• Device Regulatory Requirements • Cover multiple technologies • more new devices in a day than drugs in a year

• CI integrated into product life-cycle • GSPRs and Harmonized Standards • Common Specifications

• Clinical End-points need to establish GSPR compliance or inform Benefit-Risk Analysis so to do, using scientifically valid methodologies.

The Organisation for Professionals in Regulatory Affairs

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