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Verification & Validation
We prove your device does what it's specified to do, and what your users actually need it to do. Formal testing and documented evidence confirm the design is ready for regulatory submission and manufacturing.
Please feel out the form below and someone from our team will contact you shortly.
Phase Overview
Verification & Validation is where the design is proven rather than assumed. Verification confirms the device meets its design inputs. Validation confirms it meets user needs in the environment where it will actually be used. Testing is executed against approved protocols, results are documented, and the design history file is completed to support regulatory submission. The output is an evidence package that establishes the design is safe, effective, and ready to transfer to manufacturing.
What Happens in This Phase
Each phase draws on a different combination of our disciplines and sub-disciplines. These are the ones that generate the evidence your device needs to reach the market.
Test Planning & Protocols
Verification and validation protocols written and approved, with acceptance criteria traced to design inputs.
Design Verification
Formal testing that confirms the device meets every specification established during Design & Development.
Design Validation
Testing with representative users in simulated or actual use conditions to confirm the device meets user needs.
Biocompatibility & Sterilization
Material biocompatibility established and sterilization methods validated for the finished device and packaging.
Packaging & Shelf Life
Packaging integrity, distribution, and aging testing to establish shelf life and confirm the device arrives as intended.
Risk Management
Risk controls verified as effective, with residual risk evaluated and the risk file closed against the final design.
Design History File
Traceability completed across inputs, outputs, verification, and validation to support the regulatory submission.
Regulatory Support
Evidence assembled and organized to support your submission and respond to agency questions.
What You Walk Away With
A complete evidence package: approved protocols and executed test reports for verification and validation, biocompatibility and sterilization validation, packaging and shelf life data, a closed risk file, and a design history file with full traceability from user needs through validated design. Everything a submission requires, organized to support it.
Why This Phase Matters
Validation is a regulatory milestone, not a manufacturing one. Clearing it proves your device is safe and effective, and that matters enormously. What it does not prove is that the device can be produced consistently, at cost, and at scale. Passing this phase with a design that was built for manufacturability is what separates a cleared device from a commercial one.
Design Transfer
With the design verified, validated, and documented, the device is ready to enter Design Transfer, where the design package moves into production and manufacturing readiness is established.
Please feel out the form below and someone from our team will contact you shortly.
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