Solutions · Medical Device
Medical Device
Design controls, risk files, and DHR — as gated engines.
QMSR / ISO 13485 design controls, risk management with computed residual-risk acceptability, design history and device master records, UDI and EU MDR / EUDAMED, complaints and MDR evaluations — scored live against the clauses.
What changes. Signed DHRs, gated design transfer, and rule-driven MDR reportability — not CRUD shells.
Inside Medical Device
Different screens for a different job — this is the Medical Device stack running in the app.
The stack for Medical Device
The modules that matter here — all on one database, all sharing the same records.
The regulations, named
Not "compliance-ready" — the actual frameworks, with the workflows and live readiness that back them.
- QMSR / ISO 13485
- 21 CFR Part 11
- UDI
- EU MDR / EUDAMED
See the Medical Device stack on your own data.
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