V&V Is Where Projects Get Stuck.
Most medical technology teams know verification and validation has to happen. What slows them down is not having a clear plan for how to get there, the right test infrastructure to execute it, or documentation that satisfies a reviewer without rework.
At C3, we build and run V&V programs for medical and wellness devices — from protocol development through final test execution and documentation. We cover software, electrical, mechanical, and system-level testing, and we handle cybersecurity testing in-house — a core C3 strength — working with external certification labs only when environmental or transportation testing is required.
Since 2009, we've worked in regulated device development, and we know what reviewers look for and how to build the evidence that gets you through.
V&V Capabilities, End to End.
Programs We've Tested.
C3 built and executed a complete V&V program for a Class III combination medical device, from lab setup through regulatory submission. We analyzed system and software requirements, developed test protocols across all major test areas, fabricated custom test fixtures, and coordinated external certification testing. The program produced a complete, submission-ready design history file.
A wearable medical device team needed V&V support that could keep pace with active hardware and firmware development. C3 developed a living test protocol structure that updated with each design revision and maintained traceability throughout — so the team arrived at their submission milestone without a documentation backlog.
A diagnostics company needed both functional and performance validation for a complex instrument under a compressed timeline. C3 developed the protocols, executed the testing, and delivered final documentation directly into the client's design history file in a format their regulatory team could use without reformatting.
A simple, flexible path forward.
Talk directly with our team about your device, your regulatory pathway, and where you are in the testing process.
We define the test scope, protocol structure, and documentation approach — with project-based or retainer options that fit your timeline and stage.
Our engineers develop protocols, run testing, manage external labs, and deliver documentation while you stay focused on the decisions only your team can make.
What Working With C3 Looks Like.
Every test protocol we write is traceable to your actual system requirements, software requirements, and user needs. Not a generic checklist that has to be retrofitted to your device.
We design test conditions around how your device will actually be used, not just what is easiest to pass. That means fewer surprises in the field and fewer questions from reviewers.
Our test reports and design history file contributions are written with the reviewer in mind from the start. You do not get a data dump that needs to be reformatted before it can go into submission.
How We Approach V&V.
Good V&V starts with a clear requirements structure. We establish traceability from user needs through system requirements to test cases before any testing begins — so nothing falls through the cracks and everything can be defended.
V&V is not a gate at the end of development. We support testing at each stage so risks are surfaced early, design decisions are informed by real data, and the final submission push is not a scramble.
Regulatory-ready documentation does not happen after the testing. We build the evidence record as we execute — so your design history file is complete when testing is done, not weeks later.