NHS clinical safety
Statutory under the Health and Social Care Act 2012. An organisation cannot lawfully deploy health software in England without this, and it is the first thing a clinical safety officer asks for.
DCB0129DCB0160
Clinvera Ltd is an independent UK company providing governance assessment. It is not part of the NHS and does not act on the NHS’s behalf.
clinvera.tech · technology assurance platform
TAP turns scattered DTAC, DPIA and clinical safety paperwork into one living record you can send to any trust. Start with a free check against the 34 requirements a buyer will actually ask about.
The verification standard
Most governance packs blur the two, and a buyer cannot tell what anybody actually read. TAP separates them everywhere they appear, in the record you keep and in the summary a trust opens.
You told us the document exists. Nobody has opened it. Useful for knowing where you stand, worth nothing to a procurement team on its own.
A named Clinvera reviewer read the document against the requirement and recorded what they found. That is the part a trust can rely on, and the part you pay for.
Comparative framework
Conventional route
A regulatory consultant
£8,000 to £15,000 for a static safety case
Clinvera
A clinical gap review, and a record you keep
From £1,450
Consultant figures are the market range suppliers report, not a quotation. Clinvera pricing is being confirmed before this goes live.
Scope of assessment
Not all of them will apply to you. The check works out which do, from what your technology actually does, and tells you why the rest do not.
Statutory under the Health and Social Care Act 2012. An organisation cannot lawfully deploy health software in England without this, and it is the first thing a clinical safety officer asks for.
DCB0129DCB0160
The national gateway. DTAC is the baseline every NHS buyer applies, and the Data Security and Protection Toolkit is the annual assurance behind it.
DTAC ADTAC BUK GDPR
Whether the technology is a medical device is a question of intended purpose, not of how it is built. Getting the answer wrong is the most expensive mistake on this list.
UK MDR 2002MHRAISO 14971
The part that is specific to headsets and immersive delivery. This is where Clinvera's own protocol work sits, and where most suppliers have nothing written down.
IEEE 3079-2020Clinical practiceHealth and Safety at Work Act
Applies to every interface a patient or a clinician touches, and is assessed directly by DTAC.
WCAG 2.2 AAIEC 62366-1Accessibility practice for XR
What the technology is claimed to do has to be supported, and the people delivering it have to be competent to do so.
NICE ESFASPiHClinvera CCVRP
What a trust receives
An example of the summary a procurement or clinical safety lead opens. They see the status of every artefact and, for each one, whether it is your word or a Clinvera check.
| Artefact | Standard | Provenance | Status |
|---|---|---|---|
| Clinical safety case report | DCB0129 | Checked by Clinvera· named reviewer· 12 September 2026 | Complete |
| Data protection impact assessment | DTAC B | Provided by supplier | Complete |
| Cyber Essentials certificate | DTAC C | Checked by Clinvera· named reviewer· 30 August 2026 | Expiring soon41 days |
| Accessibility statement | WCAG 2.2 AA | Missing | |
| Simulation faculty standards | ASPiH | Not applicable |
Example record. Clinvera checks documents against published standards and does not approve a technology for use: that decision stays with the adopting organisation under DCB0160.
How it works
01
About ten minutes, no account. Questions about what your technology does, who it is used with and what you already hold.
02
Which requirements apply, which you can evidence and which you cannot, with the reason anything is ruled out.
03
Once a reviewer has checked your evidence, the record becomes a link you send instead of an email full of attachments.
The check is free and nothing is shared with anyone. You will know which of the 34 requirements apply to you before your next procurement conversation does.