Module 15 Presentations

10/04/2024

Clinical strategy notification requirements.

The role of the clinical team and regulatory governance

The Organisation for Professionals in Regulatory Affairs

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Clinical Investigation: Design Questions

How to start? Maybe by asking questions… How does your device work – what is its mechanism of action? ● This will help begin to define in whom it should be used

What condition is the device intended to treat? ● This will give you the population that should be included

In the population, are there people with characteristics or conditions that should be excluded? ● This will narrow your population to one where your device is likely to have its best effect

The Organisation for Professionals in Regulatory Affairs

40