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Assurance AI

Services

Clinical safety support, scoped to what actually blocks you

Indicative starting fees are published for transparency. Every engagement is scoped against the product, its clinical context and the evidence already available before final fees are agreed.

Service list

NHS readiness assessment

Who it is for: Suppliers approaching their first NHS deployment or procurement conversation.

Start the free readiness check

What it includes

  • Structured review of intended use and clinical context
  • Assessment against clinical safety and DTAC expectations
  • Written findings with prioritised, sequenced actions

Typical outcome: A clear, honest picture of what stands between you and a procurement-ready evidence pack.

DCB0129 clinical risk management

Who it is for: Manufacturers of health IT and AI-enabled clinical software.

About DCB0129 support

What it includes

  • Applicability assessment and scoping
  • Clinical workflow mapping and hazard identification
  • Clinical risk management plan, hazard log and safety case report
  • Clinical Safety Officer arrangements and support

Typical outcome: Clinical safety documentation that reflects the real product and withstands scrutiny.

DTAC readiness and evidence preparation

Who it is for: Suppliers preparing a submission or responding to buyer assurance questions.

About DTAC readiness

What it includes

  • Gap assessment across all five DTAC domains
  • Prioritised remediation plan with owners and effort
  • Hands-on evidence preparation and strengthening
  • Pre-submission coherence review

Typical outcome: A consistent, current evidence pack you can defend in review.

AI clinical safety assurance

Who it is for: Companies deploying AI-enabled products into clinical pathways.

About AI clinical safety

What it includes

  • Clinical hazard analysis specific to AI failure modes
  • Human oversight design that works in practice
  • Monitoring, drift and incident-response planning
  • Governance and accountability mapping

Typical outcome: A defensible account of how your AI is kept safe in use, not just at launch.

Ongoing assurance support

Who it is for: Teams that need clinical safety maintained without hiring a full function.

Discuss ongoing support

What it includes

  • Periodic review of hazards, controls and evidence currency
  • Change and release clinical safety input
  • Support responding to buyer and incident queries

Typical outcome: Assurance that stays live as the product and guidance move.

How engagements run

  1. 1. Discovery call. Free, 30 minutes, no obligation.
  2. 2. Proposal. Written scope, deliverables, timeline and fees.
  3. 3. Delivery. Collaborative, with your team, not done at a distance.
  4. 4. Handover. Documentation you own and can maintain.

Scope boundaries

We provide clinical safety and assurance support. We do not certify, approve or accredit products, and we do not provide regulatory approval or legal advice. Where your product may be a regulated medical device, or where a question is legal in nature, we will tell you to take specialist advice.

Tell us where you are stuck

Thirty minutes with a clinician is usually enough to know whether we can help.