Regulatory
Strategy
We build global strategies covering MDR, IVDR, FDA, and UKCA to accelerate market access.
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Franklyn Health
Your Device,
Our Mission.
The clinical evidence you need – to launch, grow and stay ahead.
Franklyn Health is a European CRO built for small and midsize medtech manufacturers worldwide. Our expert team bring decades of experience delivering clinical evidence for device and diagnostic partners, combining deep regulatory insight with practical trial delivery.
Your device has the power to change lives. With transparent pricing and hands-on leadership, our senior team deliver high-quality studies and regulatory support as your dedicated clinical partner, providing the strategic guidance, consistency and responsiveness you need to transform innovation into patient impact.
FULL SERVICE CRO:
Your medical device & diagnostic clinical partner from day one. From first draft of your protocol to final regulatory submission and post-market follow-up, you can count on our expertise every step of the way.
Regulatory
Study Design
& Protocol
We design practical studies that balance science and regulation — reducing risk and accelerating approvals.
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Study
Startup
We manage site contracts and ethics/ regulatory submissions to increase quality, avoid delays and reduce costs.
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Site Selection
& Monitoring
We connect you with top-performing sites and ensure data integrity through proactive, hands-on monitoring.
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Clinical Study
Management
Our team drives enrolment, ensures compliance, and provides clear updates to keep your study on track.
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Data Management
& Biostatistics
We deliver clean, reliable data and expert biostatistics for robust, compliant analyses and submissions.
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Medical
Writing
We create clear, compliant documents that communicate results effectively across MDR, IVDR, FDA, and UKCA requirements.
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OUR TEAM HAS LED AND DELIVERED COMPLEX TRIALS FOR
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