Plan verification and validation activities by requirement — specify V&V type, test phase, sample rationale, acceptance criteria, protocol IDs, regulatory clause references, and evidence links for FDA submission and ISO 13485 design control packages.
Link path: REQ rows create DV rows; DV rows point to TP protocols; TP and FMEA rows cross-reference objective evidence and risk controls. Type IDs into linked fields to generate clickable handoff badges.
FDA 21 CFR Part 820ISO 13485IEC 62366ISO 14971VerificationValidationAuto-saved
How to use this planner — the four V&V methods (FDA 21 CFR §820.30(f) / IEC 62366) click to expand
DemonstrationShow the device performs as intended in actual or simulated use — usability summative studies (IEC 62366), workflow walk-throughs.
TestQuantitative measurement against acceptance criteria using a defined protocol — bench, environmental, biocompatibility, fatigue, EMC.
Workflow: 1) pull a requirement from RTM, 2) pick the method that produces the strongest objective evidence, 3) write acceptance criteria that are pass/fail and measurable, 4) link a Test Protocol when method = Test, 5) update Status as evidence is captured. Readiness % = filled-fields / 8 (high-risk rows additionally need a regulatory clause; Passed/Failed rows need an evidence link).
Auto-saved locally
V&V ID
Req ID
Requirement Summary
V&V Type
Method
Test Phase
Risk
Sample Size
Sample Rationale
Acceptance Criteria
Protocol / Procedure
Reg. Clause
Owner
Due
Evidence
Status
Ready
No verification rows yet
Add a verification activity or load the example plan (FDA-style DV records covering all four methods: Inspection, Analysis, Demonstration, Test).