Given the need to evaluate a manufacturer/supplier DCB 0129 in order to create a DCB 0160 for digital products in a Health IT System knowledge of risk assessment using ISO 14971, which is in broad alignment with the DCB standard, would be a good idea.

At the moment the scope of DCB is too wide causing issues, so work is under way to try and limit the scope. Until this happens producing DCB 0160 for the NHS in England is going to require a lot of resources!

See https://digital.nhs.uk/services/clinical-safety/clinical-risk-management-standards for background.