How to choose a DCB 0129 consultant
before NHS go-live.
The right consultant is not just someone who can write a policy. For supplier-side DCB 0129, you need clinical risk judgement, a usable hazard process, evidence that survives DTAC or NHS buyer review, and clear Clinical Safety Officer accountability.
Short answer
What makes a good DCB 0129 consultant?
A good DCB 0129 consultant can translate your product, workflow and clinical risk into a traceable evidence file: intended use, hazard log, clinical risk management file, Clinical Safety Case Report and release decision. If you also need sign-off, the consultant should be a credible Clinical Safety Officer with enough authority to challenge the product team.
For suitable NHS digital health, SaMD and health IT suppliers, Dr Chiho Song provides this as a practising NHS clinician and contracted Clinical Safety Officer. The fixed pre-go-live DCB 0129 package is priced at £8,500, with post-go-live support scoped separately.
Selection criteria
Use these checks before appointing anyone.
The fastest way to choose badly is to buy documents without agreeing clinical accountability, evidence access or release authority.
1
Clinical accountability
Ask whether the consultant can act as the Clinical Safety Officer, or whether they only support an internal CSO. The answer changes sign-off, authority and liability.
2
Product specificity
Look for intended-use, user, setting, version and workflow analysis. Generic DCB 0129 templates do not prove that a specific release is clinically safe.
3
Hazard method
Check how hazards are identified, who attends the workshop, how causes and controls are evidenced, and how residual risk is justified.
4
CSCR quality
The Clinical Safety Case Report should be a clear safety argument with assumptions and limitations, not a pasted summary of the hazard log.
5
DTAC alignment
If procurement is the driver, the consultant should know how DCB 0129 evidence maps into DTAC's clinical safety section without contradicting security, privacy or usability evidence.
6
Post-go-live route
Ask what happens after release: surveillance, incidents, major changes, new hazards, hazard log custody and named CSO governance are usually separate from the initial package.
Which model fits?
Choose the service model that matches the risk.
Fixed package
Pre-go-live DCB 0129
Best when a defined release needs hazard log, CRMF, CSCR and CSO release memo before NHS pilot, DTAC, procurement or go-live.
DCB 0129 consultant → External challengeIndependent CSO review
Best when you need outside clinical safety challenge or an external CSO to review existing evidence for a suitable supplier-side scope.
Independent CSO → OngoingNamed CSO retainer
Best when a live product needs recurring safety governance, change review, incident review, surveillance and hazard log custody.
Named CSO retainer → ProcurementDTAC clinical safety
Best when the immediate blocker is a buyer or assessor asking for the DTAC clinical safety section and the DCB 0129 evidence behind it.
DTAC evidence → AI / SaMDAI clinical safety
Best when hazards include model drift, automation bias, unsafe confidence display, clinical escalation, monitoring and SaMD-style release control.
AI safety case → BudgetCost and pricing
Best when you need to compare the fixed package, hourly post-go-live support and named CSO retainer before committing.
See costs →
Questions to ask
Use these in the first call.
Applicability Does DCB 0129 apply to this product and release?
CSO role Who is accountable for the clinical safety decision?
Evidence What documents will be produced or reviewed?
Hazards How will clinical hazards be found and evidenced?
Scope Is DTAC, DCB 0160, medical device, cyber or data protection included?
After go-live Who owns incident review, changes and surveillance?
Good fit for Dr Chiho Song
Supplier-side NHS digital health.
Dr Song is a good fit when a suitable digital health, SaMD, clinical AI or health IT supplier needs DCB 0129 evidence, a Clinical Safety Officer release decision, a hazard log, a Clinical Safety Case Report, DTAC clinical safety evidence, or post-go-live CSO governance.
DCB 0129 support →
Not the right route
When the blocker is not clinical safety.
If the main issue is UKCA/MDR classification, ISO 13485, cybersecurity, data protection, legal contracting, clinical trial sponsorship or a deploying organisation's local DCB 0160 ownership, those streams need separate expertise or a separate scope.
DCB 0129 or medical device? →Choosing a DCB 0129 consultant?
Send the product, intended use, current evidence and NHS timeline. You will get a clear route: fixed DCB 0129 package, independent review, named CSO retainer, referral or no-fit.