Years in the making.
For the moment
that matters.

Why TORTUS pursued Class IIa.

1. §01.01
   AVT composes, it doesn't simply transcribe

   Traditional dictation records the composed thoughts of the clinician into words - AVT does the composition for the clinician - this is part of their cognitive workload. In both the positive and negative this can heavily influence the clinical workflow, making it a medical device.
2. §01.02
   Self-declaration is not validation

   Class I is self-declaration, which means any vendor can declare any software they wish to a medical device. Class IIa requires Approved Body validation, a level of rigor and scrutiny that gives assurance that the bar has actually been met.
3. §01.03
   You cannot bolt this on later

   There is a grey area around AVT specifically, but anything built on that - diagnostic coding, clinical decision support, downstream ordering - is inarguably a Class IIa device. You cannot bolt those onto a non-device after the fact. The foundation has to be solid to build.

How we operate as a Class IIa device.

284,000 words - equivalent to four full books, 136 separate documents, and a clinical evaluation architecture built from scratch. This is what it takes to operate as a Class IIa Medical Device.

1. §02.01
   An externally audited Quality Management System (QMS)

   Thousands of pages of technical documentation, audited against ISO 13485 and reviewed over months by an Approved Body.
2. §02.02
   Innovating at the frontier of clinical evaluation of large-language models

   Defining accuracy for an ambient voice system took years of work including a peer-reviewed paper in Nature Digital Medicine before any number could even be reported. 
3. §02.03
   Live post-market surveillance

   TORTUS built a post-market surveillance system — the Shell — to continuously monitor the live hallucination rate and omission rate of the system in real-time.

What does this mean for organisations exploring AVT?

Certification is not a barrier to adoption - it is the most credible route to accelerate it. It moves clinical-safety judgements from local committees to an independent assessment body, and it changes where product risk actually sits. 

1. §03.01
   Diligence performed once, used many times

   An Approved Body has appraised the device to a standard well above any single NHS process, and stakes its own accreditation on that assessment. The output is portable across trusts.
2. §03.02
   We share the risk - manufacturer, organisation and accreditor.

   Under the device regime, the manufacturer is legally answerable if the device is defective in its design, claims, or monitoring.
3. §03.03
   A regulated base layer for a long-term partnership

   Scribing is the foundation everything else is built on. The potential of having the equivalent of an AI colleague in every encounter is vast - but most of the value is in higher risk features and capabilities. Investing long-term in a regulated partner is essential to build for that future.