Safety designed in, not added on.
Software that supports clinical decisions has to earn trust. We build TrivoHealth so that every decision we make, from a line of code to a change in a clinical pathway, is evidenced, reviewed and traceable.
Clinical safety
Clinicians shape every pathway, and every clinical hazard is identified, assessed and controlled through a documented risk management process.
Information security
Patient information is protected by design, with security built into our architecture, access controls and development practices from the start.
Medical device compliance
TrivoHealth is being developed as a medical device, with the quality, lifecycle and documentation evidence that regulation requires.
A lifecycle built to produce evidence.
Our development lifecycle is designed to produce evidence aligned with recognised medical device standards and regulation.
- ISO 13485
Quality management system
A quality management system governs how TrivoHealth is designed, built, released and maintained.
- IEC 62304
Software lifecycle
Requirements, architecture, verification and maintenance follow a documented medical device software lifecycle.
- ISO 14971
Risk management
Clinical hazards are identified, evaluated and controlled throughout the product’s life, not just before release.
- IEC 62366-1
Usability engineering
Patient and clinician interfaces are designed and tested so they are safe and clear for the people who use them.
- ISO 27001
Information security management
An information security management system protects patient data across our architecture, access controls and operations.
- EU MDR
Technical documentation
Development produces the technical documentation required under the EU Medical Device Regulation.
Every pathway change is assessed, not just approved.
Clinical pathway configuration changes can affect how the device performs, so each one goes through a documented regulatory assessment before it reaches patients.
- 1
Proposed change
A pathway or configuration change is requested and recorded.
- 2
Clinical review
Clinicians assess the change for clinical appropriateness.
- 3
Regulatory assessment
The impact on device performance and regulatory status is assessed and documented.
- 4
Verification
The change is tested against its requirements and risk controls.
- 5
Controlled release
Only approved, verified changes reach patients, with a full audit trail.
Our principle: clinical approval alone does not determine regulatory acceptability. Both are required, and both are documented.
Questions about our approach?
We’re happy to talk through our safety, security and regulatory approach in more detail.