If your product touches clinical decisions, patient pathways, triage, prescribing, or safety-critical workflows, you are in DCB territory. Investors, procurement, and DTAC-style assurance increasingly expect a credible clinical safety function—not a last-minute PDF.
DCB0129 in one line (UK)
DCB0129 sets clinical risk management requirements for organisations responsible for developing and maintaining health IT systems used in health and care environments (i.e., suppliers/manufacturers). DCB0160 is the complementary standard for the deploying/using organisation.
What the CSO actually “signs” (the deliverables that matter)
Clinical safety assurance is essentially clinical risk management. The core artefacts are the Hazard Log and the Clinical Safety Case Report (plus supporting evidence), demonstrating hazards have been identified, assessed, mitigated, and are acceptable at release.
Pricing: charge for releases, not for feelings
A practical contracting model is to price per “Safety Release” (e.g., v1.2 → v1.3), where you deliver: hazard workshop → updated hazard log → updated safety case → sign-off pack.
Market anchors (indicative): some contract CSO roles advertise ~£475/day; specialist consultancies publish day rates around ~£895–£1,050/day depending on risk and scope. Your rate is a function of accountability, turnaround, and whether you are the named CSO.
Source
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