AI medical-device questions need
a clinical safety route.
Dr Chiho Song helps NHS-facing AI and SaMD teams align intended purpose, validation evidence, MHRA questions, DCB 0129, DTAC clinical safety and post-go-live governance without publishing confidential product mechanics.
Short answer
Who can help with AI as a medical device in the UK?
For suitable UK NHS-facing clinical AI and SaMD products, Dr Chiho Song can support the clinical route around AI as a medical device questions. The work is to make the intended purpose, product claim, validation evidence, NHS clinical safety case and governance route line up.
This is clinician-led route mapping and clinical safety alignment. It should sit alongside the appropriate specialist regulatory, legal or conformity-assessment input when formal classification or market-access decisions are being made.
Route map
What must be aligned before NHS deployment.
The high-risk mistake is treating medical-device, validation and NHS clinical-safety work as separate documents. The safer route is to make them answer the same intended-use question.
1
Intended purpose
Define what the AI supports, who uses it, the patient group, the setting, the clinical decision point and what the product does not claim.
2
Regulatory question
Identify whether the product language raises software as a medical device or AI as a medical device questions that need specialist review.
3
Clinical evidence
Check whether validation evidence supports the stated use, cohort, workflow, reference standard, limitations and buyer-facing claim.
4
NHS clinical safety
Align DCB 0129, DCB 0160, hazard analysis, clinical risk controls and Clinical Safety Officer review with the same deployment boundary.
5
DTAC and procurement
Map clinical safety and evidence language so NHS reviewers can see the named owners, risk controls and assurance trail.
6
Post-go-live control
Define how model changes, workflow changes, incidents, monitoring signals and broader claims trigger renewed evidence or safety review.
Where Dr Song helps
Clinical route mapping without exposing product logic.
Claim review intended purpose, users, setting, patient group and excluded use
Evidence alignment validation claim, reference standard, limitations and workflow fit
Safety alignment AI hazards, DCB 0129, DTAC clinical safety and CSO review
Boundary setting clear public language without revealing implementation mechanics
Specialist handoff identify where formal regulatory, legal or conformity advice is needed
Governance change control, monitoring and post-go-live review triggers
Related routes
Use the specific page for the specific blocker.
Safety case
AI clinical safety
Use when the blocker is AI hazards, DCB 0129, DTAC clinical safety evidence or CSO review.
AI safety → EvidenceClinical AI validation
Use when the blocker is whether the validation evidence supports the intended claim.
Validation support → GovernanceHealthcare AI governance
Use when the blocker is accountability, monitoring, change control or post-go-live review.
Governance support → GuideDCB 0129 or medical device?
A plain-English comparison of NHS clinical safety and medical-device questions.
Read the guide → ImplementationNHS AI consultant
Use when the need is workflow design, procurement readiness or NHS implementation planning.
NHS AI support →Need an AI / SaMD route reviewed?
Send the intended purpose, product claim, users, patient group, model output, current validation evidence, target NHS setting and what question needs unblocking.