Verification and Validation (V&V) plan template
Artifact · Verification & Validation
A V&V plan names, before execution begins, exactly which verification and which validation activities are planned against what acceptance criteria, with 100% of the ISO 14971 risk controls traced to a planned verification activity.
This template is the starting structure — download it, fill it against your own safety classification, and put it through your own quality system's review before treating it as approved.
What a V&V plan needs to separate
Per Verification vs. Validation, the two are independently evidenced activities. A V&V plan that lists verification and validation as one combined "testing" section is already the most common way this artifact fails an IEC 62304 review for MedTech software — the template below keeps them apart on purpose.
Engineering reference template only. Not an approved plan, not formal regulatory counsel. Version: 1.0.0. Requires your own quality system's review and sign-off before use. The full template is below, in the Artifact section — generated client-side, no server round-trip.
Artifact: vv-plan-template.md
Generated client-side; no server round-trip, no account required.
# Verification and Validation (V&V) Plan Template (v1.0.0)
Engineering reference template only. Not an approved plan until reviewed and
signed under your own quality system.
## 1. Scope
- Software item(s) covered:
- Safety classification (A/B/C) and rationale:
- Applicable standards (e.g. IEC 62304, ISO 14971):
## 2. Verification activities
- [ ] Unit implementation and verification (per unit, Class B/C)
- [ ] Integration testing (interfaces per architecture)
- [ ] System testing (against software requirements)
- [ ] Code review / static analysis records
## 3. Validation activities
- [ ] User needs analysis
- [ ] Intended-use / use-environment definition
- [ ] Validation test protocol (against user needs, not just requirements)
- [ ] Human factors / usability evidence, where applicable
## 4. Traceability
- Reference: the Requirements-to-Test Traceability Matrix for this item
(see /resources/standards/requirements-test-traceability)
## 5. Risk-control verification
- Each risk control from the ISO 14971 file has a corresponding verification
record confirming it is implemented and effective.
## 6. Acceptance criteria
- Explicit pass/fail thresholds per activity, agreed before execution begins.
## 7. Roles and sign-off
- Author:
- Technical reviewer:
- Quality approval:
- Date:
Useful next step
Provenance & review state
- Last reviewed
- Sources
-
- IEC 62304:2006+AMD1:2015 — International Electrotechnical Commission
- ISO 14971:2019 — International Organization for Standardization
- Ingested from
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