Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Practical Implementation

 Stuarts Risk Management File recipe  You will need...  Preheated oven (top management buy-in)  Roughly diced Device family groups  1x freshly prepared Risk Management Plan

 1x bunch Cross-functional subject matter experts  1x set Clinical benefit, Intended Purpose assessments  1x tin Risk assessments , various sizes  1x sachet Pro-active post market surveillance system  (Note: Other recipes may vary)

The Organisation for Professionals in Regulatory Affairs

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Practical Implementation

 Top Management buy-in essential  Provision of adequate resource  Appropriate qualified personnel  Part of Quality Management Review  Broad understanding of approach is beneficial

Money

People

Time

Benefit

The Organisation for Professionals in Regulatory Affairs

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