Clinical safety
We apply DCB0129 to our own software. We also help other digital health manufacturers meet it, with the documents, the clinical judgement and a named Clinical Safety Officer.
What DCB0129 asks of a manufacturer
- Clinical Risk Management Plan
- How you will manage clinical risk for the product: scope, roles, method and the criteria for acceptable risk.
- Hazard Log
- Every credible way the product could contribute to patient harm, with causes, controls and residual risk, kept current as the product changes.
- Clinical Safety Case Report
- The argument and evidence that the product is acceptably safe for its intended use, written for a customer’s safety team.
- Clinical Safety Officer
- A named, suitably qualified and experienced clinician who owns clinical risk management and signs off the safety case.
Fractional Clinical Safety Officer
A named, accountable clinician for your product, part time, without a full-time hire.
- Named Clinical Safety Officer with the sign-off authority the standard requires.
- Hazard workshops with your developers and product team.
- Review of changes that could affect patient safety before they ship.
- Support through customer assurance and procurement.
Available as an ongoing role or as a defined project, such as building your first safety case.