Compliance & safety

Built to be trusted with a patient record.

The checklist a practice lead works through before signing — declared up front, not buried in a security PDF sent on request.

UK MDR 2002 medical device — MHRA self-certification route. Scope intentionally narrow.device

Risk management file maintained across the product lifecycle.risk

Clinical safety case for health IT systems, with a named clinical safety officer.safety

DPIA on file. UK data residency, EU disaster recovery. PHI stripped at the analytics SDK.data

Accessible by design — for tremor, low vision, fatigue and one-handed use.access

Target certification. Secrets management, audit trail and break-glass built in.security

No risk scoring, no automated escalation, no AI inference, no diagnosis — by design. The clinician decides; Plasticity keeps the record.

What it does — and won't do.

Crossing these lines would reclassify the device. We keep the line bright on purpose.

We'll bring the DPIA, hazard log and clinical safety case to the demo. Ask the awkward questions.