Dr Chiho Song

For founders & CTOs

Your product works. Now show it’s safe.

NHS organisations ask suppliers for DCB 0129 clinical safety evidence before a digital health product is deployed.

Why it matters

Every clinical product carries hazards.

Controls are layers of defence. Harm can reach a patient when the gaps line up.

Clinical Safety Officer

I find the gaps and close them.

I trace each hazard to its controls and the evidence that they work.

Scope and hazard workshop

Start with intended use.

We agree users, setting and release boundary, then run one facilitated hazard workshop with your product, clinical and engineering leads.

Hazard log

Every hazard scored.

Causes, clinical harms and owners recorded, with risk scored for severity and likelihood before mitigation.

Controls

Risk reduced, with evidence.

Controls traced to verification, with residual risk scored and justified.

Safety case

Your evidence, documented.

Clinical Safety Case Report, Clinical Risk Management File, hazard log and safety requirements. I sign off only when the evidence supports it.

Fixed scope, fixed fee

Ready for NHS review.

Scope and fee agreed up front, with a four-week target from kickoff where the product, evidence and team are ready.

The deploying organisation keeps its own DCB 0160 responsibilities.