Risk Management Plan

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.

Mapping of Standard Requirements to Document Sections

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

1. Relevant Processes

1.1 Risk Management Process and Activities

Risk Management Activities are integrated in the Software Development Lifecycle as described in SOP Integrated Software Development.

1.2 Risk Policy and Risk Acceptability

Criteria for Risk Acceptability are defined in the Risk Acceptance Matrix.

1.3 Verification of Risk Control Measures

Risk Control Measures are verified as described in SOP Software Development Lifecycle.

1.4 Assessment of the overall residual risk

After determination of the Risk Control Measures any risk that could arise from the combination of the individual risks or mitigating measures is assessed. For this purpose, the probability and severity of the possibly residual risk are estimated and evaluated using the existing risk matrix.

1.5 Collection and Review of Post-Production Information

Review and collection of Post-Production information is described in SOP Post-Market Surveillance.

2. Related Documents

• SOP Integrated Software Development
• Risk Acceptance Matrix
• Risk Table
• Risk Management Report

3. Roles

Title	Name(s)
Risk Manager
Context / Subject Matter Expert, e.g. physician

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