ORTHON Safety Readiness Review

Independent clinical safety assurance, before it matters

A structured review of your organisational processes, documentation and governance against DCB 0129 and DCB 0160 — delivered by National leads in digital clinical safety. Designed to give you a clear picture of where you stand and what's needed next.

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What the review covers

01
Evaluating submissions against relevant artefacts
02
Producing a structured output
03
Providing a clear outcome with rationale
04
Identifying required actions for clinical and clinical safety SMEs

Who this is for

Health technology manufacturers preparing for DCB 0129 compliance, hazard assessment, or Clinical Safety Case Report documentation — including suppliers preparing for a DTAC assessment, where the review directly evidences the "Clinically Safe" criterion. NHS organisations needing DCB 0160 deployment safety assurance, procurement review, or board-level AI governance support. International health systems embedding safety standards across borders.

Why an independent review

This isn't a generic audit run from a checklist. The review is carried out by practitioners who have operated inside DCB 0129 and DCB 0160 at a national level — not just advised on them — so the output reflects what demonstrably good practice looks like in the field, not just what the paperwork says.

Get in touch for your clinical safety check-up

No commitment — just an open initial conversation to understand where you stand on DCB 0129 / 0160 and your direction of travel.

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