Module 14 2022

22/03/2022

Conclusions

1. RISK ASSESSMENT AND RISK MANAGEMENT ARE KEY ACTIVITIES FROM THE VERY START OF ANY DESIGN PROCESS ● ..and the process must be continued throughout the life cycle of a product

2. RISK MANAGEMENT IS PART OF NORMAL LIFE ● It’s something we do every day ● It’s required across all industries

3. The methods used for devices are no different to other industries.

Masterclass: Lecture 2

The Organisation for Professionals in Regulatory Affairs

39

Example risk assessment form from UK HSE for retail activities

Masterclass: Lecture 2

The Organisation for Professionals in Regulatory Affairs

40

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