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The Risk Management Plan contains the relevant processes and activities which will be conducted for product-specific risk management. In this case, it mainly references other documents because most risk management activities are part of the integrated software development process (SOP Integrated Software Development). Also, the risk policy and acceptability are defined in the Risk Acceptance Table, and the actual risks are in the Risk Table.
| ISO 14971:2019 Section | Document Section |
|---|---|
| 4.1 | 1 |
| 4.2 | 1.2, 3 |
| 4.3 | (Records of competence are kept as Part of QMS) |
| 4.4 | (all) |
| 4.5 | (all) |
| 5.1 | 1.1 |
| 7.2 | 1.3 |
| 10.1 | 1.4 |
Risk Management Activities are integrated in the Software Development Lifecycle as described in SOP Integrated Software Development.
Criteria for Risk Acceptability are defined in the Risk Acceptance Matrix.
Risk Control Measures are verified as described in SOP Software Development Lifecycle.
Review and collection of Post-Production information is described in SOP Post-Market Surveillance.
| Title | Name(s) |
|---|---|
| Risk Manager | |
| Context / Subject Matter Expert, e.g. physician |
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