Medical Device *Clinical Trials*

Cool medical device. Where’s the data?

How does Citruslabs run studies for Medical Devices? Citruslabs designs and runs IRB-approved clinical studies tailored to Medical Devices brands — consumer perception studies (4–8 weeks, $15K+), single-arm clinical studies (8–12 weeks, $40K+), or randomized controlled trials (12–16 weeks, $80K+). Each study uses category-appropriate endpoints and biomarkers, ships with a marketing claims appendix reviewed for FTC and FDA best practices, and earns the optional Citruslabs Tested Seal if the data supports product claims.

Clinical trials for consumer medical devices — wearables, sleep tech, dermatology tools, and more.

Built for *real-world device use*

People use medical devices in bedrooms, gyms, offices, and on the couch. Not under fluorescent clinic lights at 9am on a Tuesday. Our decentralized and hybrid study models reflect how your device is actually used in the world. Participants engage from home with digital data capture and telehealth check-ins where needed. If baseline or validation visits are required, we build them in without grinding everything to a halt. The result is faster enrollment, more representative participants, and data that reflects real performance. Not lab performance.

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Categories

Study Types

Frequently Asked Questions

Does my device need FDA clearance before running a clinical trial?

No. You don’t need FDA clearance to conduct a clinical study. Most consumer wellness devices qualify as non-significant risk (NSR) and can proceed with IRB approval alone — no IDE required. We handle the classification assessment and IRB submission.

What’s the difference between a 510(k) and a De Novo submission?

A 510(k) is for devices with an existing predicate — you’re demonstrating ‘substantial equivalence.’ A De Novo is for novel, low-to-moderate risk devices without a predicate. We design studies that generate the specific evidence each pathway requires.

How is a device trial different from a supplement trial?

Device trials typically require objective endpoint measurement (not just surveys), device-specific adverse event monitoring, usability/human factors testing, and documentation that meets FDA device guidance. We build all of this into the study design from day one.

What study designs do you support?

RCTs, single-arm studies, pilot/feasibility studies, real-world evidence collection, and usability/human factors testing. We recommend the design based on your device class, regulatory pathway, and business goals.

Can you run studies for both Class I and Class II devices?

Yes. Class I devices typically don’t require clinical trials for clearance, but many brands run them voluntarily for marketing claims and competitive positioning. Class II devices pursuing 510(k) clearance need performance data — we design studies that meet that bar.

How fast can a device study be completed?

Most studies run 8–16 weeks depending on complexity. Simple performance validation can finish in 8–10 weeks. Multi-endpoint RCTs typically take 12–16 weeks. Our decentralized trial model eliminates the recruitment delays that slow down traditional CROs.

Testimonials

We needed clinical data for our 510(k) submission. Citruslabs designed the study, recruited 80 participants in 3 weeks, and delivered a data package our regulatory consultant said was the cleanest he’d seen from a CRO.

Michael Huang, VP Regulatory Affairs

The hybrid model was perfect for us — site visits for device fitting and imaging, then remote follow-up. Our participants loved the flexibility and our retention rate was 94%. Unheard of in device trials.

Jessica Walsh, Director of Clinical

Our De Novo submission required specific clinical evidence that most CROs didn’t know how to generate. Citruslabs understood the FDA’s expectations for a novel device category and built the study around those requirements from day one.

Robert Chen, CEO & Founder