BS EN 62304 — Software Safety Class A
Developed and maintained under a lifecycle process compliant with BS EN 62304. Requirements, architecture, verification, release and post-market change are all controlled processes with retained records.
DeepInfinity Scribe is UKCA marked Class I medical device software, registered with the MHRA, developed under EN 62304 and DCB0129, and supported by a completed NHS DTAC v2.0 self-assessment.
DeepInfinity Scribe — comprising DeepScribe AI, DeepConverse AI and DeepSpeed Rad Scribe — is classified as Class I medical device software under the UK Medical Devices Regulations 2002 (as amended). Conformity is self-declared by the manufacturer and the device carries the UKCA marking.
| Device | DeepInfinity Scribe (Medical Device Software) |
|---|---|
| Classification | Class I, UK MDR 2002 (as amended) |
| Conformity route | Self-declared, UKCA marked |
| Manufacturer | DEEPINFINITY LTD, 1 Benton Road, Ilford, Essex IG1 4AT, United Kingdom |
| Company number | 13093821 |
| MHRA registration | Confirmed 30 July 2026 |
| MHRA account number | 0000038833 |
| Public register | Listed on the MHRA Public Access Registration Database (PARD) |
| Declaration of Conformity | Available on request |
Registration with the MHRA is a legal requirement for placing a medical device on the Great Britain market. It does not represent accreditation, certification or approval of the device by the UK Competent Authority, and we do not describe it as such.
For a Class I device, conformity with the essential requirements is declared by the manufacturer against its own technical documentation. That documentation is what an assurance team should ask to see — and we provide it.
DeepInfinity Scribe captures speech and produces draft clinical documentation for review, editing and approval by a qualified healthcare professional. Every output is a draft. Nothing enters a patient record until a clinician approves it.
We are deliberate about what the device is not. DeepInfinity Scribe is not intended for autonomous diagnosis, treatment decisions, clinical triage, image interpretation, abnormality detection, or patient monitoring. Its intended purpose is documentation, and that boundary is what its Class I classification rests on.
A Class I registration covers a defined intended purpose, not a company. Clinician review does not reduce a device classification — classification follows intended purpose, so software that interprets an image or calculates a severity score sits in a different class regardless of who signs the output off.
Any DeepInfinity product with a diagnostic or decision-support purpose requires its own classification determination and conformity assessment route, and is not covered by this registration.
Developed and maintained under a lifecycle process compliant with BS EN 62304. Requirements, architecture, verification, release and post-market change are all controlled processes with retained records.
Risk management applied across the product lifecycle, with a documented risk management file, hazard analysis and residual risk evaluation maintained for each module.
Design, development and release operate within a certified quality management system, audited independently in July 2026 with zero non-conformances.
We operate a clinical risk management system compliant with DCB0129: Clinical Risk Management — its Application in the Manufacture of Health IT Systems, the NHS standard that applies to us as a manufacturer.
Clinical Safety Officer: Zoe Alexandra Oparah
DCB0129 covers us. DCB0160 covers you. Deploying organisations are responsible for their own clinical risk management, and we support that directly: our Clinical Safety Case Report, Hazard Log and residual risk statements are available to your Clinical Safety Officer under NDA, so your DCB0160 assessment can be built on our evidence rather than assumptions about it.
The Digital Technology Assessment Criteria is the baseline the NHS uses to assess digital health technologies at the point of procurement. We have completed the DTAC v2.0 self-assessment in full and provide it to NHS organisations on request.
| Domain | Covered by |
|---|---|
| Clinical safety | DCB0129 compliance, named Clinical Safety Officer, Clinical Safety Case Report and Hazard Log |
| Data protection | UK GDPR and DPA 2018, ICO registration ZC195380, DPIAs, ROPA, Article 28 data processing agreements |
| Technical security | ISO 27001:2022, Cyber Essentials Plus, independent penetration and API security testing |
| Interoperability | Integration across EHR, EPR, PACS, RIS and HIMS; structured output; authorised API access |
| Usability and accessibility | WCAG 2.2 AA accessibility statement, clinician-in-the-loop workflow design |
DTAC is a supplier self-assessment that the buying organisation reviews. It is not a certification, and no body issues a DTAC approval — so a supplier describing itself as “DTAC certified” is overstating it.
Certified information security management system. Stage 2 audit completed July 2026 with zero non-conformances.
Certified quality management system covering product development, release and support.
Independently verified technical controls, including MFA across all in-scope cloud services.
Regular third-party VAPT across application, infrastructure and APIs, with formal remediation and retest.
Rather than send documents piecemeal through a procurement cycle, we provide a single assurance pack. Tell us which documents you need and we will confirm what can be shared openly and what requires an NDA.
DEEPINFINITY LTD · 1 Benton Road, Ilford, Essex IG1 4AT, United Kingdom · Company No. 13093821
DeepInfinity Scribe is Class I medical device software under UK MDR 2002. UKCA marked. Registered with the MHRA. Registration is not approval by the UK Competent Authority.