sinraStructure your software development before your first audit.
For medtech and healthtech startups, Sinra connects requirements, development, tests, and release validations in a single tool. Your traceability builds up as you develop, not the night before the audit.
Jira for devs, Excel for traceability, Word for validations
In healthcare, software isn't enough: you need to prove how it was specified, built, verified, and validated. Most young teams piece this evidence together by hand, with spreadsheets that are never up to date.
Requirements linked to code and tests.
Every specification is linked to the issues that implement it and the tests that verify it.
Formal, logged validations.
Phase reviews with evaluation criteria, a go / no-go / conditional verdict, and a history of every decision.
Documented incidents.
Structured postmortems: timeline, systemic factors, remediation actions, resolution time.
A shared vocabulary.
A business glossary shared and reused across specifications, to avoid ambiguity.
The rigor of the V-model, the pace of agile
Specs follow their own writing and validation flow, while developers move in short cycles. Tests and phase reviews ensure nothing ships without being verified.
Hosted in France, GDPR, encrypted data
Sinra is built for your development data, not patient data. As in your test environments, use fictional or anonymized data in your issues and attachments.
Sinra is a development organization tool. It is not a certification and does not by itself guarantee compliance with a standard (for example IEC 62304 or ISO 13485). It helps you structure and retrieve the documentation your quality process expects.