DCB 0129 clinical safety case,
built for NHS go-live.
Dr Chiho Song is a practising NHS clinician and contracted Clinical Safety Officer. He helps digital health and SaMD teams turn product risk into a credible DCB 0129 evidence pack: hazard log, clinical risk management file, clinical safety case report and signed CSO release memo.
If you are looking for a DCB 0129 consultant.
You are probably trying to get through NHS procurement, DTAC, a trust pilot or a go-live review without the clinical safety work becoming a late blocker. This page is the short route: Dr Chiho Song provides DCB 0129 consulting and Clinical Safety Officer sign-off for manufacturers of health IT systems deploying into the NHS.
For the full commercial scope, use the DCB 0129 / DCB 0160 compliance page; for transparent pricing, use the Clinical Safety Officer cost page. For the role itself, see Clinical Safety Officer services. If the buyer has asked for the CSCR, hazard log or CRMF specifically, use the Clinical Safety Case Report and hazard log page. If your immediate blocker is the clinical safety section of DTAC, use the DTAC clinical safety evidence page. If you need ongoing supplier-side named CSO support after the initial safety case, use the contract Clinical Safety Officer page.
What the DCB 0129 package produces.
The work is designed for a product team that needs usable evidence, not a generic policy bundle.
Intended-use and workflow scope
Define users, setting, patient group, decision points, dependencies, contraindicated use and deployment assumptions.
Hazard workshop and hazard log
Identify credible clinical hazards, causes, controls, owners, verification evidence and residual risk.
Clinical risk management file
Bring the plan, hazard log, safety requirements and supporting evidence into a traceable file.
Clinical Safety Case Report
Write the safety argument for the defined release and deployment context, with assumptions and limitations explicit.
Post-market surveillance plan
Set out the process for incidents, safety monitoring, change review and hazard log updates after go-live.
Signed CSO release memo
The accountable statement that residual clinical risk is acceptable for the defined release and context.
Best for product teams approaching NHS deployment.
Digital health manufacturers, SaMD teams and suppliers preparing for DTAC, trust pilot, procurement review or clinical safety committee sign-off.
Not medical-device or legal advice.
DCB 0129 does not replace MHRA medical device classification, UKCA/CE work, cybersecurity, data protection or local DCB 0160 deployment assurance. Those streams need to align, but they are not the same.
Need DCB 0129 handled before the NHS asks?
Send the product, intended use, target NHS organisation and timeline. You will get a clear yes, no, or referral.