Resources: artifacts
Every approved artifacts resource node.
Index
Architecture Decision Record (ADR) Template — Regulatory-Traced
The Architecture Decision Record (ADR) template: context and trade-off records mapped to ISO 13485:2016 §7.3.4 Design Outputs (former 21 CFR §820.30(d)) and ISO 14971 Clause 7.1 Risk Control Options Analysis.
Verification and Validation (V&V) Plan Template
A downloadable Verification and Validation (V&V) plan template for regulated software: verification activities, validation activities, traceability reference, risk-control verification, acceptance criteria, and sign-off — scoped to IEC 62304 and ISO 14971.