Templates and records · ISO 13485 · Clause 7.3.6 y 7.3.7

ISO 13485 design verification and validation

Two different questions, each with its own record: does the design meet what was specified? And does the device serve its intended use in the hands of its real users?

In one sentence

Design verification and validation are recorded with a plan setting out methods, acceptance criteria and, where appropriate, statistical techniques with a rationale for sample size, and with a report of results and conclusions, because ISO 13485 requires verification that outputs meet inputs (7.3.6) and validation on representative product, before release, that the device meets its intended use, including the clinical or performance evaluation required by regulations (7.3.7).

Content reviewed on 17 October 2026

Where the standard requires it: ISO 13485 · Clause 7.3.6 y 7.3.7 Clauses are cited using the numbering of ISO 13485:2016, the current edition and the same one the Academy uses.
Type of information: Mandatory record Records of results, conclusions and actions to be retained (7.3.6 and 7.3.7)
Who fills it in: Design, with in-house or external laboratories Clinical validation is led by staff with suitable clinical qualifications
When: At the stages set in the design plan Always before release, and again when a design change requires it
How long it is kept: Product lifetime, at least two years ISO 13485 requires records to be kept for at least the lifetime of the device as defined by the manufacturer, and never less than two years from release (4.2.5); the MDR requires technical documentation to be available for ten years after the last device was placed on the market, fifteen for implantables (Article 10(8)).

What the standard requires

What ISO 13485 demands and what it leaves to your judgement

Verification compares outputs with inputs: tests, calculations, inspections or document reviews. The standard asks for documented plans with methods, acceptance criteria and statistical techniques where applicable, and for it to be recorded if the device connects to other devices, so that interface is checked too.

Validation checks the device against user needs and intended use. It must be done on representative units — initial production batches or equivalent — and the choice of product used is justified in writing. It includes the clinical or performance evaluation required by regulations; in the EU, that of Article 61 and Annex XIV of the MDR.

Both are completed before the product is released, and product used for clinical validation is not considered released to the customer.

Read it in context: Product realization, in the ISO 13485 Academy

Structure

Fields the template should include

Requirement or design input being checked
Type: verification or validation
Test method or standard and laboratory
Acceptance criterion defined before testing
Sample: units, batch and statistical rationale for size
Justification that the product is representative (validation)
Raw results and conclusion
Deviations and how they were handled
Person reviewing and approving the report

Example

Example: accuracy verification and usability validation

Company, people and figures are fictitious: the example only shows what a properly completed record looks like.

Field	Content
Verification	SpO2 accuracy on a simulator against the ±2% requirement · protocol VP-PX-07
Sample	30 units from 3 pilot batches · size justified for 95% confidence and 90% reliability
Result	Maximum error 1.6% · conforming
Validation	Summative usability study with 15 home users and 15 nursing professionals
Product	Units from the first production batch, made with the transferred documentation
Result	1 critical use error: value read with the finger incorrectly positioned
Action	Positioning indicator redesigned and validation repeated: 0 critical errors
Approval	Technical director · 2 September 2025

At the audit

Mistakes auditors commonly flag

Acceptance criteria set after seeing the results.
Sample sizes without justification ("three units out of habit").
Validation done with prototypes that do not represent the series product.
Laboratory verification confused with user validation.
Subcontracted tests whose reports are not reviewed or approved internally.

In Kimobox

How this record is kept in Kimobox

1Protocols and reports are managed as controlled documents with versions and approval.
2Each report is linked to the design file and to the device it validates.
3A deviation during validation is opened as a nonconformity, with a mandatory root cause and verification of effectiveness.

Frequently asked questions

What people ask us before getting started

What is the difference between verifying and validating the design?

Verifying answers "did we build it right?": outputs meet inputs. Validating answers "did we build the right thing?": the device meets user needs and intended use under real or simulated conditions.

Is clinical evaluation part of validation?

Yes. ISO 13485 includes in validation the clinical or performance evaluations required by regulations. In the EU, the MDR requires a clinical evaluation for every medical device, with the scope appropriate to its class and risk.

Keep your ISO 13485 records without loose templates

We'll show you the module running with data similar to yours.

Request a demo

Keep exploring