Clinical Safety Statement

Renvia is a clinician-in-the-loop remote monitoring platform. Clinical safety is a first-class engineering and governance concern. This statement summarises how we manage clinical risk and how we support deploying organisations.

Scope and intended use

Renvia is intended for use by qualified clinicians to support the remote monitoring of adult patients with cardio-renal-metabolic conditions, under a named clinical pathway. Renvia does not make autonomous clinical decisions and is not a medical device. It surfaces prioritised information to support the clinician; the clinician remains responsible for diagnosis, treatment and escalation.

DCB0129 — Manufacturer safety case

• Renvia maintains a Clinical Safety Case File and Hazard Log in line with DCB0129.
• Our Clinical Safety Officer (CSO) is a registered clinician with current professional indemnity.
• Every material release is reviewed for clinical impact; hazards, controls and residual risk are documented and re-assessed.
• The current Clinical Safety Case Report is available under NDA to prospective and active customers on request.

DCB0160 — Deployment support

Deploying organisations retain the DCB0160 obligation as operator of the health IT system. Renvia supports DCB0160 activity with:

• A Deployment Hazard Log template covering local configuration, integration and workflow risks.
• User training material, escalation protocol templates and a go-live checklist.
• Named CSO-to-CSO liaison during onboarding, incident response and material changes.

Incident reporting

Clinical safety incidents or near-misses must be reported to safety@renvia.health. We triage all reports within one working day, share our findings with the responsible facility's CSO, and notify the MHRA where reporting thresholds are met.

What Renvia is not

• Not a substitute for emergency care — in an emergency, call 999.
• Not a diagnostic device — outputs are decision-support only.
• Not intended for unsupervised patient self-diagnosis or self-titration.