Your Clinical Safety Officer
for NHS go-live.
I'm a doctor with NHS clinical experience and a Clinical Safety Officer in England. I prepare and review DCB 0129 clinical safety cases for digital health suppliers, with sign-off where the evidence supports it. DCB 0160 deployment support is scoped separately.
Who and what.
I'm a doctor with NHS oral and maxillofacial surgery experience and a Clinical Safety Officer based in England. I support digital health and SaMD teams with DCB 0129 clinical safety cases, independent review and named CSO work. DCB 0160 support is scoped separately with the deploying organisation. For a plain-English definition, see what a Clinical Safety Officer is; for role suitability, see Clinical Safety Officer requirements; for the hiring checklist, see how to hire a Clinical Safety Officer; for budget planning, see Clinical Safety Officer cost.
The role, in plain terms.
A Clinical Safety Officer leads clinical risk management, reviews the evidence and approves the Clinical Safety Case Report. The manufacturer and deploying organisation retain their own responsibilities for risk acceptance and release or deployment decisions.
Hazards & risk
Runs the hazard workshop, builds the hazard log and clinical risk management file, and scores risk before and after mitigation.
The safety case
Writes the DCB 0129 clinical safety case report and safety requirements specification that auditors, DTAC and NHS trusts expect to see.
Go-live release
Reviews the clinical safety evidence and residual risk for the defined release. CSO approval supports the organisation's release decision; it is not blanket approval for every deployment.
The signature has to mean something.
A clinical safety case is an accountable clinical judgement, not a paperwork exercise. The value of a Clinical Safety Officer is that a registered clinician — one who understands the real workflows your SaMD has to be safe inside — is willing to put their name to the statement that residual risk is acceptable.
I draw on NHS experience across wards, clinics and theatres when reviewing hazards. The safety case connects that clinical context to your product's evidence, controls and intended use. Read the NHS clinical risk management standards →
Independent challenge, with the access to do it properly.
For suppliers in England, an external CSO can prepare a safety case, review an existing evidence pack, or provide ongoing named CSO support. The engagement needs access to the product, workflow, evidence and change history, plus authority to challenge release decisions.
A defined safety case
Intended-use review, hazard workshop, hazard log, Clinical Risk Management File and Clinical Safety Case Report for an agreed supplier product release. Sign-off depends on the evidence and residual risk.
Fixed-fee package →Review or CSO handover
Start with a two-hour £250 review, followed by a capped estimate. Handover work is £125/hour, typically 6–10 hours, depending on the evidence and outstanding actions.
Review and handover pricing →A named CSO
From £800/month for suitable stable or low-change products, including up to three hours. Additional work is £125/hour; higher-change products are scoped separately.
Named CSO retainer →Supplier-side DCB 0129 work does not replace the deploying organisation's DCB 0160 responsibilities. It also does not replace medical-device conformity assessment, legal advice, cyber assurance or data protection work. Send the product, intended use, target NHS organisation, timeline and current hazard log or CSCR →
What's included — and what's not.
The fixed-fee package covers the agreed pre-go-live evidence and CSO review. Sign-off depends on the evidence and residual risk; ongoing support is scoped separately. See the cost guide →
The pre-go-live safety case
Hazard workshop, clinical risk management file and hazard log, DCB 0129 clinical safety case report, safety requirements specification, written post-market surveillance plan, and the signed CSO go-live release memo — prepared to a four-week target, subject to evidence readiness and resolution of safety actions.
After go-live
Running post-market surveillance, safety and incident reviews, hazard log updates, sign-off of major product changes or new hazards, DTAC and DSPT cross-walks, and recurring governance are scoped separately so the fixed fee stays fixed.
Independent or external CSO support →Clinical safety, answered.
What is a Clinical Safety Officer?
A suitably qualified clinician, trained in clinical risk management, who is accountable for the clinical safety of a health IT system. DCB 0129 and DCB 0160 require a named CSO to review and approve the clinical safety case before a system is used in patient care. Read the full explainer →
What is DCB 0129?
The NHS standard for clinical risk management in the manufacture of health IT systems. It requires manufacturers to run a clinical risk management system and produce a hazard log, clinical risk management file and clinical safety case report, signed off by a CSO.
What is DCB 0160?
The companion standard for organisations that deploy and use health IT — NHS trusts and care providers. It requires the deploying organisation to manage clinical risk through its own CSO when it configures, deploys and uses a system.
When do I need a CSO?
When a health IT system or SaMD is used by or within the NHS and the DCB standards apply — which covers most products heading for NHS deployment, though applicability varies by product and setting. Where applicable, the clinical safety evidence supports DTAC assessment and local procurement and deployment decisions. It does not replace the buyer's wider assurance checks.
Can you support NHS clinical safety cases?
Yes. I prepare and review clinical safety cases for suitable digital health and SaMD products, with sign-off where the evidence supports it. Supplier-side DCB 0129 and deploying-organisation DCB 0160 work are scoped separately. Reach me at cs@csong.health.
How do I hire a CSO in England?
Send your product, timeline and the NHS organisation you're deploying into. Available routes include a fixed-fee DCB 0129 package (£6,000, with a four-week target subject to evidence readiness); review, change, incident and handover work (£125/hour); and supplier-side named CSO retainers from £800/month for suitable stable or low-change products. Hire an independent CSO →
Need a named CSO on your safety case?
Tell me the product, the timeline and the NHS organisation you're deploying into. I aim to reply within two working days with a next step or, where appropriate, a referral.