For engineering & R&D leaders
Every discipline and artifact connected and always traceable, with change-impact across the whole program. Your engineers stay in their tools; the system of record keeps itself current.
Change one input and see everything it affects before a review surfaces it late. Traceability & change →
US/EU variants and parallel fielded versions as branches of one system of record; merge with the trace intact. Branching & variants →
CI delivers automated test results as records citing the exact commit, authenticated per job with no stored secret; coverage reflects what actually ran. Integrations →
Avera Drive puts the project in Finder and Explorer; CAD assemblies and BOMs extract into items, proposed for review. Avera Drive →
IEC 62366 use scenarios and use errors analyzed in the same chain as your dFMEA: use-related risks traced to the design and IFU controls that mitigate them, formative and summative evaluations captured as records.
Load the standards you own (60601, 62304, 62366) as clause trees: clauses link to the requirements, hazards, and tests that address them, with coverage per clause, live.
Software items, classification, and verification mapped onto the same connected model.
Automated results count as verification of the unit they test; a renamed test shows as unexecuted.
For the whole device record, not just the repository.
Dependencies and their risk assessments live in the record, versioned and traceable.
A design input changes; instantly see the affected requirements, risks, tests, and BOM lines across disciplines. Branch to fix a fielded complaint without forking your toolchain, then merge with the trace intact.
They work in their native applications through Avera Drive; AI removes grunt work rather than adding it; the record keeps itself current.
Configuration, not code: no admin army, and your data exports completely.
REST for everything, MCP for your agents, per-job CI identity for your pipelines.