V&V Master Plan Toolkit
Verification and validation planning templates — master plan, verification protocols, validation protocols, traceability matrix, test reports, and failure investigation — ready for FDA Design History File and regulatory submission.
What You Get
V&V Master Plan Template (FDA Design Controls + ISO 13485)
Top-level verification and validation master plan aligned with FDA 21 CFR 820.30 design controls and ISO 13485 Section 7.3. Covers V&V scope, test levels (unit, integration, system), acceptance criteria methodology, traceability to design inputs, and the management review and sign-off structure FDA inspectors review during design control audits.
Design Verification Protocol Template
Structured verification protocol template for confirming design outputs meet design inputs. Covers test objective, acceptance criteria, test method description, sampling rationale, equipment requirements, and the pass/fail documentation format. Includes separate sections for dimensional verification, material verification, and performance verification.
Design Validation Protocol Template (Simulated Use + Human Factors)
Clinical and simulated use validation protocol template confirming the device meets intended use requirements under actual or simulated use conditions. Covers validation test scenarios, user population definition, simulated use environment, use error analysis, and the statistical rationale for sample size selection.
V&V Traceability Matrix Template
Bidirectional traceability matrix linking design inputs to verification activities and validation test results. Structured to demonstrate 100% input coverage and to identify any design input that lacks a corresponding verification or validation test. Pre-formatted for Design History File inclusion and 510(k)/PMA submission as a design controls summary.
Test Report Summary Template
Standardized test report template for documenting V&V results. Covers test objective, protocol reference, test execution dates, equipment and materials used, deviations from protocol, results data, pass/fail determination, and the authorized signature block. Structured for both internal DHF documentation and regulatory submission.
V&V Failure Investigation and Retest Protocol
Structured process for investigating V&V test failures and determining when retesting is appropriate. Covers failure classification (protocol deviation vs actual failure), root cause investigation methodology, corrective action requirements before retest, retest authorization, and the documentation standards that prevent FDA from questioning the integrity of your V&V program.
FAQ
What is the difference between design verification and design validation?
Verification confirms design outputs meet design inputs (did we build it right?). Validation confirms the device meets user needs and intended uses under actual or simulated conditions (did we build the right thing?). Both are required under FDA 21 CFR 820.30.
When should the V&V Master Plan be written?
Ideally at the beginning of the design phase, before verification or validation testing begins. The master plan defines the overall V&V strategy and must be in place before individual protocols are executed.
What format are the documents?
All documents are editable Word and Excel templates ready for direct use in your Design History File.
Ready to get started?
For informational purposes only. Not legal or regulatory advice. Legal