Clinical trial planning and execution for medical devices. From study design to enrollment to regulatory submission support. We're not a big pharma CRO. We're a medical device CRO built for lean teams who need real execution, not a 40-person oversight committee.
Most CROs hand you a project manager and a process. We hand you a team of biomedical engineers who understand your device, your regulatory pathway, and what the FDA actually needs to see. That engineering foundation means fewer protocol errors, faster study design, and clinical data that holds up through submission, not just through enrollment.
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Protocol development, statistical planning, and regulatory pathway alignment to set your study up for success.
Identify, contract, and manage clinical sites that can actually deliver on enrollment and data quality.
Strategic enrollment support to keep your study on timeline without blowing your recruitment budget.
Clean data collection, monitoring, and statistical analysis that meets FDA requirements.
We guide you through every phase of your clinical study with hands-on project management and regulatory expertise.
Protocol development, regulatory strategy, budget, and timeline. Clear plan before we start.
Site selection, IRB submissions, contract negotiation, and study initiation. Get sites ready to enroll.
Patient enrollment, data collection, site monitoring, and quality oversight. Keep the study on track.
Statistical analysis, clinical study reports, and regulatory submission support. Get your data FDA-ready.
Early-stage clinical evidence to inform design iterations and regulatory strategy. Small-scale, fast enrollment.
IDE studies and 510(k) supporting trials for FDA submissions. Full GCP compliance and regulatory alignment.
Real-world evidence, PMCF studies, and post-approval commitments. Demonstrate long-term safety and effectiveness.
Head-to-head device comparisons and substantial equivalence studies for 510(k) pathways.
Formative and summative usability studies to meet FDA human factors requirements (HE75).
Long-term data collection and observational studies for ongoing safety monitoring and market access.
We understand medical device trials, not just drug studies adapted for devices. Know the difference between substantial equivalence data and pharma endpoints.
Fixed-fee or milestone-based pricing designed for device budgets. No hidden costs, no scope creep surprises.
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Our clinical team are engineers first. We understand device mechanics, failure modes, and FDA technical requirements. Which means we design studies that generate the right evidence, not just compliant paperwork.
Whether you're planning a pilot study or a pivotal trial, let's talk about your clinical research needs and how we can support you.
Book a Discovery CallPractical, plain-English guides written for lean device teams.
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