Verification & validation

Proof that the device meets its requirements and works in real hands. Every protocol traces back to the risk file held under ISO 14971.

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When verification and validation are the right step

When the design is stable enough to test against its requirements. Verification and validation turn the design file into evidence a regulator and an auditor can check.

Prove each requirement
Bench tests that show each design output meets the design input it answers.
Show it works for users
Design validation and summative usability testing with real users in realistic conditions.
Prepare for accredited labs
Protocols, samples and pre-checks before safety, EMC or biocompatibility testing at an accredited lab.

What you bring, and what you get back

You bring

Design inputs and requirements
The risk management file
Design outputs: drawings, schematics and software
Units to test, built the way production will build them
Any test results so far

You get back

Verification and validation plan
Test protocols with acceptance criteria
Test reports
Accredited lab reports, where a standard needs them
Requirements trace matrix
Summative usability report

Verification and validation answer different questions

Verification asks whether each design output meets its design input, usually on the bench. Validation asks whether the device meets the user's needs for its intended use, with real users in realistic conditions. ISO 13485 expects validation on initial production units or their equivalent, so units built by hand in the lab may not count. A device can pass every verification test and still fail validation.

How verification and validation work

Step 1
Plan
A verification and validation plan traced to the requirements and the risks.
Step 2
Write the protocols
Each test with its method, its sample and its acceptance criteria.
Step 3
Test
In-house, and at accredited labs for the standards that need them.
Step 4
Report
Reports and a trace matrix that shows every requirement covered.

Questions clients ask

When should verification and validation planning start?

When the requirements are written. A requirement that cannot be tested cannot be verified, so the plan checks each one early, while it can still be rewritten.

How many samples do we test?

The plan sets it for each test from the risk of failure and the confidence needed, and records why. Some standards also set a minimum.

Which tests need an accredited lab?

Tests to recognised standards, such as IEC 60601-1 electrical safety and IEC 60601-1-2 EMC, are usually run at a lab accredited to ISO/IEC 17025. Many other tests can run in-house under a controlled protocol.

What is a trace matrix?

A table that links each requirement to its design output, its risk controls and the test that proves it. It shows a reviewer that nothing was missed. See the design history file.

An assembly bench with tools and parts trays

Tested in-house and at accredited labs

Tests run in our own labs in Navi Mumbai, and at accredited labs for the standards that need them. Verification is one of nine disciplines in one team, so the test engineers work beside the designers.

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