Medical device design verification

Design verification vs. validation

Verification confirms the device was built correctly. Validation confirms the right device was built. Both are required, and verification comes first.

Design validation

Tests the device against user needs and intended use

Runs in real or simulated clinical use with representative users

Confirms the right device was built for the people who use it

Acceptance criteria come from user needs and are often qualitative

Design verification

Tests design outputs against design inputs

Covers specifications, dimensions, performance, software behaviour, and risk controls

Runs on the frozen design through bench testing and analysis

Acceptance criteria are quantitative and fixed before testing begins

Medical device verification at Perdigó

Verification testing begins once the design is frozen at the end of detailed design. Every activity traces back to a design input or a risk control, and the evidence it produces feeds directly into your technical file or design history file. You are not left assembling documentation under pressure.

Verification planning

Scope, methods, and acceptance criteria defined before any testing begins, traceable to design inputs from the outset.

Functional and performance testing

Bench testing to confirm the device performs against every design output under relevant conditions of use.

Mechanical verification

Stress, fatigue, and dimensional testing to confirm structural and physical integrity against specifications.

Software verification

Unit, integration, and system-level testing aligned to IEC 62304 lifecycle requirements and software safety classification.

Electrical safety and EMC verification

Verification against IEC 60601-1 and applicable collateral standards for electrical safety and electromagnetic compatibility.

Formative usability evaluation (IEC 62366)

User-facing studies that identify and mitigate use-related risks and feed the usability engineering file.

Risk control verification (ISO 14971)

Confirmation that every risk control in the risk management file has been implemented and works, updated in parallel with testing.

Verification protocols and reports

Complete, structured, traceable documentation of every activity, ready for the technical file or DHF without further assembly.

Why choose Perdigó for verification?

Full-device scope under one team

Mechanical, electrical, software, and usability verification are managed by a single team. We also manage and oversee biocompatibility and sterility tests with partners. The programme stays coherent and traceable to one standard.

Complete, compliant documentation

Every protocol, report, and traceability record is written to the standard a reviewer expects: complete, traced to a specific design input, and consistent with your risk management file.

Built for EU MDR, FDA, and UKCA

We develop medical devices for the EU, UK, and US markets, in strict accordance with the relevant regulations and requirements and across all stages.

Trusted by medical device leaders

We have helped medical device innovators turn ideas into market-ready products.

“Perdigó’s mechanical design team showed impressive skills, particularly around tolerance analysis. Our collaboration on Design for Manufacturing and Assembly (DfMA) was very productive as a result.”

Gabe German

Senior mechanical design engineer Phillips Medisize (a Molex company)

“Perdigó's risk management work, engineering documentation and expert advice have supported the successful regulatory submission and approval of the Airway Shield device."

Julio M. Alonso

CEO and Chief Medical Officer, Airway Medical Innovations

"Perdigo is a great partner for your device development. Their expertise and capacity to adapt to your needs makes them a great choice to work with."

Laura Andrade

R&D, Innovation & New Products Associate Director, Insud Pharma

Clear, streamlined engagement

Working with Perdigó is straightforward by design.

01 Scoping call

We discuss your current status, your needs, and objectives. There is no commitment at this stage, simply an honest view of whether we are the right fit.

02 Needs assessment meeting

Our medical device experts assess your development needs and requirements in detail, ensuring that both teams are fully aligned before any work begins. An NDA is signed around this point.

03 Proposal

You receive a clear proposal that defines the engagement scope, deliverables, timeline, and investment.

04 Kick-off and collaboration

Our team runs verification planning, protocol development, testing, and documentation. Throughout, you receive progress updates, alongside regular checkpoints where we shape direction together and agree the key decisions.

05 Handover and next steps

You receive the complete verification record and a recommended path forward, which depending on the outcome, could involve moving into pilot manufacturing.

Perdigó's medical device regulatory team

FAQs

1. What is the difference between design verification and design validation?

Verification confirms the device was built correctly, testing design outputs against design inputs through bench testing and analysis. Validation confirms the right device was built, testing it against user needs in real or simulated use. The sequence is clear: the design is frozen, verification confirms it was built correctly, and validation follows.

2. What does medical device design verification include?

It typically includes verification planning, functional and performance testing, mechanical verification, electrical safety and EMC verification, software verification under IEC 62304, formative usability evaluation under IEC 62366, and risk control verification under ISO 14971. Each activity is documented in a verification protocol and report and traced back to a specific design input.

3. What is a design verification protocol?

A design verification protocol is a document that defines what will be tested, the method, and the acceptance criteria, traced to a specific design input or risk control. It is reviewed and approved before testing begins, and the results are recorded in a verification report that provides objective evidence the input was met.

4. What happens if a verification test fails?

A failed result is a finding, not a dead end. The result is recorded as it stands, the cause is investigated, and the outcome usually points to one of three things: the design output needs revising, the design input or its acceptance criterion was wrong, or the test method itself was unsuitable. Whichever it is, the affected records and the risk management file are updated and the activity is re-run against the agreed criterion. Verification is not complete until every input has a passing, documented result.

5. Does a design change mean repeating verification?

Not all of it. The traceability matrix shows which design inputs the change touches and which verification activities depend on them, so re-verification can be scoped to those activities rather than the whole programme. This is why the matrix is built as the work happens: without it, a late change to one component can be impossible to bound, and the safe answer becomes retesting everything.

6. How many units are needed for verification testing?

It depends on the input being verified and the risk attached to it. Some activities are satisfied by a single unit or by inspection, while others require a sample size with a documented statistical rationale, particularly where a risk control is being confirmed. Sample sizes and their justification are set out in the verification plan before testing begins, because a reviewer will ask why a given number was sufficient.