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Clinician using a finished medical device with a patient in a clinical setting
Prepare & Launch

Clinical Readiness

Bridge the gap between a working prototype and a market-ready device. We help medical and wellness device companies prepare for FDA submission, clinical trials, and launch.

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Your Device Works. Now It Has to Prove It.

A working prototype is a major milestone. It's also not enough. Before your device reaches patients, it has to clear FDA review, pass V&V testing, and arrive at clinical trials with the documentation to back it all up.

Clinical Readiness is the structured process of getting there. We identify what's missing, build what's needed, and prepare you for submission with confidence.

Who This Is For.

  • Companies with a working prototype preparing for FDA submission
  • Teams approaching clinical trials who need V&V testing and design history support
  • Founders who built the device but don't have in-house regulatory expertise
  • Companies whose device was built elsewhere and now needs regulatory work closed out

What Clinical Readiness Covers.

FDA Gap Analysis
We assess your device against FDA requirements and deliver a prioritized roadmap of what's needed to be submission-ready — across design controls, V&V testing, documentation, and regulatory pathway.
Verification & Validation Testing
V&V is the proof your device works safely and consistently. We design test protocols, execute verification, and validate performance. When testing reveals gaps, our engineering team closes them in-house.
Design History File (DHF) Build & Remediation
Most devices arrive at this stage with documentation scattered. We build or remediate your DHF so it tells the complete story your submission requires.
Regulatory Pathway Strategy
510(k), De Novo, PMA, or IDE — choosing the right pathway is one of the most consequential decisions you'll make. We help you pick the right one and build the evidence to support it.
Pre-Submission Meeting Support
Pre-submission (Q-Sub) meetings are one of the most underused tools in the industry. We help you prepare the briefing package and frame the right questions to turn FDA feedback into a faster, cleaner submission.
Clinical Trial Readiness
Heading to clinical trials? We prepare the engineering and documentation foundation: IDE submission support, protocol-relevant testing, and the infrastructure clinical sites need to use the device safely.

A simple, flexible path forward.

01
Clinical Readiness Assessment

The first step in the process. We show you where you stand and what's left to do. Depending on product complexity, this takes a few days to a few weeks.

02
Close the Gaps

Our engineering team executes the V&V testing, documentation, and engineering work needed to close every gap. No third-party handoffs.

03
Submit With Confidence

You walk into FDA submission, clinical trials, or launch with the documentation, testing, and strategy to support the strongest outcome.

What Makes C3 Different in Clinical Readiness.

Two engineers reviewing a medical device alongside regulatory documentation to identify and close a gap
We Identify Gaps — and Close Them

Most regulatory consultants give you a report and walk away. We tell you what's missing AND we have the engineering team to fix it: firmware updates, hardware revisions, test harness builds, documentation remediation.

A medical wellness device displayed with its electronics board, firmware module, and regulatory documentation
Medical and Wellness Technology Only

This is not a generalist regulatory practice. Over 25 years working exclusively on medical and wellness technology means we know what FDA reviewers actually look for.

Experienced engineer carefully examining a small medical wellness device under focused light
Cross-Disciplinary Under One Roof

When gaps surface across electronics, firmware, cloud, and documentation, you don't need to assemble four vendors. We handle all of it in-house.

How We Approach Clinical Readiness.

Honest Assessment First

We'd rather give you a hard truth about what's needed than a soft pitch that creates problems later.

Pathway-Specific Planning

510(k), De Novo, PMA, and IDE submissions each have different evidence requirements. We tailor readiness work to your specific pathway.

Documentation Built to Hold Up

Your DHF, V&V records, and risk management documentation should hold up under FDA review. We build them that way from the start.

We Meet You Where You Are

Whether you've worked with us from the start or you're coming to us with a device built somewhere else, we can step in.

Frequently Asked Questions.

How is Clinical Readiness different from regulatory consulting?+
We're not regulatory consultants. A regulatory consultant produces the documentation that goes to the FDA. C3 runs the gap analysis and then closes those gaps with our own engineering team — compiling the documentation, testing, and engineering evidence you need, and helping you understand what to share with the FDA and how to answer their questions.
Do you support 510(k), De Novo, and PMA submissions?+
Yes. We work directly with your regulatory consultant — or one of our regulatory partners — to build a Design History File with everything the FDA needs for your submission.
What if my device wasn't built by C3?+
Common and completely fine. The gap analysis is designed to give you a clear picture of where things stand, regardless of who built the device.
How long does Clinical Readiness usually take?+
It starts with our — the first step in the process — which shows you where you stand and what's left to do. Depending on the complexity of your product, the assessment can take anywhere from a few days to a few weeks.
Can you handle the FDA submission itself?+
No — and that's by design. A regulatory consultant's role is to represent you to the FDA, much like a lawyer represents a client. We provide the documentation and engineering expertise; they make sure the right level of detail reaches the FDA.

Clinical Readiness Work We've Done.

Elira wearable neurostimulator device
Elira: From Wearable Concept to FDA Trials

C3 developed the custom hardware, firmware, and companion app for Elira's wearable neurostimulator — then fully documented the design process to secure FDA approval for a clinical trial.

Read the Elira Case Study

Ready to Get Your Device Submission-Ready?

The gap analysis is the right first step. Talk with our team and get a clear picture of what stands between you and FDA submission.

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