Medical Device Design Verification Protocol Template
A design verification protocol states, before any testing, what will be tested, on how many units, by what method, and what counts as a pass. This template gives you that structure so it can be reviewed and approved ahead of the test.
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Medical Device Design Verification Protocol Template
Design Verification Protocol
Company: Acme Medical Devices Inc. Protocol No: DVP-0042 Revision: A Device: Single-use infusion set, model IS-200 Date: 2026-10-20
1. Objective and Scope
Demonstrate that the design output meets the specified design inputs for flow rate accuracy and tubing joint tensile strength.
Design input(s) verified: DI-017, DI-018 (flow rate, tensile strength)
2. Sample Plan
Sample size: 30 units Rationale: Binomial, 95% confidence, 90% reliability, zero failures allowed
Samples must come from units built to released drawings and approved process, with lot numbers recorded on the data sheet.
3. Test Method
Gravity flow at 1 m head height with water at 23 C, collected over 10 minutes. Tensile pull at 200 mm/min on a calibrated load frame.
4. Acceptance Criteria
Flow rate 100 mL/h +/- 10%. Joint tensile strength not less than 15 N with no separation.
5. Equipment and Calibration
Load frame LF-07 (cal due 2027-02-01), balance BAL-03 (cal due 2027-01-15)
6. Results Record
| Sample ID | Lot | Measured value | Pass / Fail | Tester initials |
|---|---|---|---|---|
| 1 | ||||
| 2 | ||||
| 3 |
7. Deviations
Record any departure from the protocol, the reason, and the impact assessment. Overall result: Pending
Approvals
Starting point only. Align the format with your design control procedure and keep the protocol approved before testing begins. Not legal or regulatory advice.
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An optional review of how to link test records to lot and equipment data.
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How to use the template
Fill in the fields on the left and the document updates on the right. Start with the design input reference, because every verification test should trace to a specific design input. Then set the sample size with a stated rationale, write the method in enough detail that another technician could repeat it, and state numeric acceptance criteria. Export to PDF or Word, route it for approval, and only then run the test. Results go in the table or on attached raw data sheets.
- Trace each test to a design input ID
- State the sample rationale, not just the number
- List calibrated equipment by ID
- Approve the protocol before testing
What the standards expect
ISO 13485 clause 7.3.6 and FDA 21 CFR 820.30(f) require design verification to confirm that design outputs meet design inputs, with results, the method, and the date and individuals performing it documented. FDA is moving to the Quality Management System Regulation, which incorporates ISO 13485, but the verification expectation stays the same. The protocol is the place where the plan is fixed in advance, which is what auditors look for.
Common mistakes
The most frequent finding is acceptance criteria written after seeing the data. Others include samples taken from prototype builds that differ from the released design, uncalibrated equipment, and no rationale for the sample size. Verification is also confused with validation: verification asks whether you built the device right against the inputs, validation asks whether the device meets user needs in the intended use.
- Criteria set after testing
- Prototype samples instead of design-frozen units
- Missing calibration status
- Mixing up verification and validation
Frequently Asked Questions
What is the difference between design verification and validation?
Verification confirms design outputs meet design inputs, usually through bench tests, inspection or analysis. Validation confirms the finished device meets user needs and intended use, often under actual or simulated use conditions with production-equivalent units.
How do I justify a sample size?
Use a statistical rationale tied to risk, such as a binomial confidence and reliability calculation for attribute data or a tolerance interval for variable data. Higher risk characteristics need higher confidence and reliability.
Can I change the protocol mid-test?
Only through a documented amendment or deviation with approval and an impact assessment. Silent changes are a typical audit finding.
Does this template replace my procedure?
No. It is a starting format. Follow your own design control procedure for numbering, approvals and record retention.
If your protocols and results live in documents disconnected from your ERP lot and equipment records, Netray can help link them. Ask for a short review.
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