Development of an NHS Health IT Clinical Safety Management System (CSMS) compliant to DCB0129 (clinical safety risk management).

Note: This is not required (as already included) if opting for the Class I SaMD QMS (see above).

The QMS should be implemented into the Client’s system used for tracking of software development (e.g. Confluence/Jira).  Add on apps for digital signatures (eg. Comala), testing (eg. TestRail or Zephyr) and risk management (eg. Risk Manager) will be required.

It is also possible to deliver the CSMS as a series of Word documents and templates, however this is more difficult and time consuming for the appointed CSO to work with and not as methodical and traceable.

Standards

• DCB0129:2018 (clinical safety risk management)

Additional activities (Client responsibility)

Digital system fees

Standards audits/certifications