Rebecca Wilson
Founder & Managing Director
What AVT compliance looks like
Ambient voice technology sits at the intersection of AI, clinical software and medical device regulation. It records live clinical conversations and produces structured outputs, which means transcription errors, hallucination, consent and safety-netting must all be evidenced.
DigiSafe has written clinical safety and regulatory evidence for AVT products already deployed across NHS trusts, ICBs and health boards.
Our AVT compliance package
- DCB0129 file with AVT-specific hazards (transcription, hallucination, consent, safety-net)
- DCB0160 deployer support for trusts and ICBs rolling out AVT
- DTAC v2 completion
- Medical device classification, technical file and UKCA/MHRA pathway
- ISO 42001 and EU AI Act readiness
- Post-market monitoring and clinician-in-the-loop workflows
Frequently asked questions
What is AVT (ambient voice technology)?
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Ambient Voice Technology, often called an AI scribe, records clinician-patient conversations and generates structured notes, letters or coded outputs. In the NHS it is regulated as clinical software and, in most cases, as a medical device.
Do AVT scribes need DCB0129?
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Yes. Any AVT product used in NHS clinical care needs a DCB0129 file with AVT-specific hazards, including transcription accuracy, hallucination, consent, safety-net workflows and clinician review.
Is an AVT scribe a medical device?
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Usually yes. If the output informs a clinical decision, coding, prescribing, referral, discharge, it typically meets the definition of Software as a Medical Device under UK MDR and needs UKCA marking and MHRA registration.
What about DTAC v2 for AVT?
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Every NHS AVT deployment goes through DTAC v2, clinical safety, data protection, security, interoperability and usability. We complete the full pack.
How does DigiSafe help AVT vendors?
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We're the UK's most active clinical safety team for AVT, writing DCB0129, DTAC, medical device files and AI assurance evidence for scribe products already deployed in trusts and ICBs.
Related services
Talk to an Expert
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Direct clinical access
Meet the team, Clinical Safety Officers, DPOs & Medical Device Experts.
Multi-disciplinary lived experience across nursing, GP, paramedic, pharmacy, medical devices and data protection. Book a discovery call and we'll match you with the right expert.
Stacey Dudley
Chief Operating Officer
Alice Wood
Head of Clinical Safety and Compliance
Suzanne Ash
Medical Device and Compliance Expert
Tom Falcon
Medical Device and Compliance Expert
Steve Robson
Clinical Safety Officer, Nurse
Dr Lizzie Marston
Clinical Safety Officer, GP
Mona Kapinga
Clinical Safety Officer, Pharmacist
Dr Aleem Qureshi
Clinical Safety Officer, GP
Matthew Olsson
Clinical Safety Officer, Lead Trainer, Paramedic
Zara Mahmood
Clinical Safety Officer, Occupational Therapist
Shell Mcvey
Business Support Manager
Clarity
Marketing Partner & Digital Strategist
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