Early access registrations are open for Headstart, a predictable, fixed-price program for becoming compliant.

Updated April 20, 2021

Template: Risk Management Plan

Dr. Oliver Eidel
ISO 14971

This is a free template, provided by OpenRegulatory.

A preview of the template is shown below. You can download it as Word (.docx), PDF or markdown file.

The template license applies (don't remove the copyright at the bottom).

Download as:
Beginning of template

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 Collection and Review of Post-Production Information

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

3. Roles

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

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

End of template

Questions?

Regulatory compliance is not rocket science.

But finding a good consultant is.

No Cookie For You Privacy Policy Imprint
No QMS on this planet will save you from creating crappy software.