Clinical software earns trust by being inspectable, and that applies to the company as much as the code. This page sets out the standards Orwyn is being built to, and where each one stands today. Where work is in progress, it says so: formal conformance claims will be made only when the relevant assessment or certification is complete.
DCB0129 is the NHS clinical risk management standard for manufacturers of health software. It requires a named Clinical Safety Officer who is a suitably qualified and experienced clinician. That role is held by Dr Arj Imbuldeniya, appointed on 19 August 2026, who is also the author of the clinical rules. The standard permits this and it is usual at our stage, so we state it plainly rather than imply a separation that does not exist.
A hazard log and a clinical risk management plan are in place. The nine knee safety rules are approved for implementation and for evaluation. They are not approved for live clinical use: that additionally requires the completed clinical safety case report, and the deploying organisation's own assessment under the companion standard, DCB0160, which we support. Independent clinical review is planned before first deployment and is not yet in place.
Status: Clinical Safety Officer appointed 19 August 2026; safety rules approved for implementation and evaluation; safety case report in progress; independent review planned, not yet in place.
Orwyn is health technology built to the engineering and documentation standards expected of regulated clinical software under UK medical device regulation, with specialist regulatory advice taken before any classification commitment, and the intention to certify.
Status: built to the standard from the first line of code; classification confirmed with regulatory advice before launch.
The DTAC is the NHS's baseline assessment for digital health technologies, covering clinical safety, data protection, technical security, interoperability and usability. Orwyn is being mapped against every DTAC criterion as it is built, so that assessment is a formality rather than a scramble.
Status: mapping in progress.
UK GDPR by design, with data minimisation as the starting point rather than an afterthought. This website sets no cookies and runs no analytics or tracking. Cyber Essentials certification is planned ahead of first deployment, alongside the NHS Data Security and Protection Toolkit.
Status: data minimisation live today; certifications scheduled before deployment.
In its first version, Orwyn asks nothing of patients: no app, no login, no password, and nothing collected back from the patient. The handover a patient receives is read-only, handed over by their clinician in the room. For an information governance reviewer, the shortest route through a data protection impact assessment is a product that barely collects data, and that is a design decision, not an accident.
The reference pages on this site are written by Dr Arj Imbuldeniya, consultant orthopaedic knee and hip surgeon, drawing on national guidance from NHS England and the relevant professional bodies, with every substantive claim linked to its source. If anything is out of date or wrong, tell us and it will be corrected. No organisation named or linked on this site has reviewed, approved or endorsed Orwyn.
We would rather answer a hard question early than an easy one late.
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