Our prototype phase begins
We're starting to build TrivoHealth's first working prototype with clinicians at the table, and laying the groundwork for certification from day one.
TrivoHealth has officially entered its prototype phase. After shaping the idea with the people who work in emergency care every day, we’re now turning it into something clinicians can see, test and challenge.
Building with clinicians, not just for them
Triage is a clinical process first and a software problem second. That’s why clinicians are involved in every part of the prototype, from the wording of patient questions to the information that appears on the clinician view.
Over the coming months we’ll be:
- Testing the patient check-in flow to make sure the questions are clear and accessible for everyone who walks through the door.
- Refining the clinician view so the most important information is visible at a glance, without adding to anyone’s workload.
- Reviewing clinical pathways with emergency clinicians to make sure every assessment is consistent and grounded in evidence.
Setting up for certification
Software that supports clinical decisions has to meet a high bar, and we’d rather build towards it from the start than retrofit it later.
Alongside the prototype, we’re putting the foundations in place for medical device certification. Our development lifecycle is designed to produce evidence aligned with:
- ISO 13485 for our quality management system
- IEC 62304 for the medical device software lifecycle
- ISO 14971 for risk management
- IEC 62366-1 for usability engineering
- ISO 27001 for information security management
- EU MDR technical documentation
We’re also building in a principle that matters for any configurable clinical system: changes to clinical pathways can affect how the device performs, so every change needs a documented regulatory assessment. Clinical approval alone doesn’t determine regulatory acceptability.
It takes more work up front, but it means every step we take is one we can stand behind when TrivoHealth reaches real patients. You can read more about our approach on our clinical safety & governance page.
What’s next
We’ll share more as the prototype takes shape. If you’re a clinician who’d like to help test it, or a healthcare provider interested in an early pilot, get in touch.