Clinical safety you can evidence, not just claim.
Vikela turns DCB0129 and DCB0160 from a one-off document exercise into a living process — assessment, hazard logging, safety case evidence and post-market surveillance held together in one disciplined workflow.
One workflow for the whole safety lifecycle.
Most teams keep clinical safety in scattered documents that go stale the moment a product changes. Vikela keeps assessment, hazards, evidence and monitoring connected and current.
Phased safety assessment
A structured DCB0129/0160 assessment that walks a product through clinical risk management, stage by stage, with nothing skipped.
Living hazard log
A DCB0129/0160 hazard log that stays current as the product and its risks evolve — controls, severity and ownership held in one place.
Safety case evidence
Assessment and hazard data assemble into Clinical Safety Case Report-ready output — evidence traced back to its source.
Post-market surveillance
Two-tier monitoring so the safety signals that surface after deployment don't slip out of view or out of governance.
Governance packs
Generates the documentation set your safety governance actually needs to review, sign off and audit against.
Traceable by design
Every decision is time-stamped and linked, so an assurance trail exists when a board, a regulator or an auditor asks for one.
Assess. Log. Evidence. Monitor.
The same four moves a clinical safety officer makes by hand — held in one place, kept current, and ready to show.
Work the assessment
Move through structured clinical risk assessment aligned to DCB0129, stage by stage.
Capture every hazard
Record hazards, controls and evidence in a DCB0160 log that stays live as the product changes.
Assemble the case
Pull the safety case and governance documentation together from a single source of truth.
Watch what comes next
Track post-deployment safety signals with two-tier surveillance, so assurance doesn't stop at go-live.
In active development with a small group of early partners.
Vikela is being built and refined alongside NHS and digital health teams. Previews are by request — book a walkthrough and see whether it fits the way your safety governance already works.
Book a walkthrough