- Clause 6.1, Actions to address risks and opportunities.
This clause addresses the risks and opportunities when planning for the quality
- Clause 8.1.1, Operational risk management.
This clause addresses the risks associated with the operational processes needed for
the provision of products and services.
Our risk management exercise will take you through the analysis of risks for the product realization steps required for your products. The exercise is intended to provide a simple approach to risk management that can be applied to all types of medical device products where risks can vary and be very different depending on the nature of the products.
- 32-page Risk Analysis Exercise (MS Word)
- 28-slide presentation of the risk analysis exercise
- Risk and opportunity worksheet
- Project planning worksheet.