Module 19 2021

02/06/2021

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)

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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

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