Designed for Medtech teams planning PMCF or pivotal studies who need realistic recruitment forecasts and a country strategy that fits EU MDR, UKCA, and Notified Body expectations.
Get a comprehensive view covering recruitment reality, competing trials, and regulatory context before you commit budget to your clinical program.
Tailored support for manufacturers at critical regulatory junctures.
A growing Medtech company planning its first multi-country trial in Europe was unsure which countries and centers could realistically recruit, especially with limited budget and internal resources.
The sponsor launched a lean study that met recruitment targets without constant amendments. They successfully demonstrated to Notified Bodies that their country choice was entirely data-based.
An established manufacturer needed PMCF data for MDR but was unsure which European countries and centers could deliver follow-up in routine practice for a Class III implant.
The PMCF study enrolled steadily and generated Real-World Data that fed directly into the Clinical Evaluation Report (CER) and PMCF Evaluation Report, establishing a clear rationale for the chosen sites during Notified Body review.
A US-based company wanted its first EU study but had little knowledge of European healthcare systems or which countries were realistic for recruitment and approval timelines.
The sponsor secured a three-country design with predictable timelines, met expectations at Ethics and Competent Authorities, and built a strong story for future market access discussions.
Short slide pack capturing your device, indication, target markets, endpoints, recruitment goals, and key feasibility questions.
Country-by-country view of standard of care, patient pathways, reimbursement context, and competing medical device studies.
Spreadsheet mapping potential investigators and centres, patient volumes, previous device trial experience, and KOL feedback.
Prioritised list of countries and sites split into Wave 1 and Wave 2, with a clear, data-backed rationale for every recommendation.
Excel-style model with projected monthly enrollment, expected start-up timelines, and key risk flags ready for internal planning.
We hold a kick-off meeting to understand your device indication, objectives, and constraints. Together we agree on target countries, success criteria, and key questions.
Keeps everyone aligned from the start. It avoids assumptions and ensures our feasibility work focuses on decisions that matter for your trial.
Device overview, clinical and regulatory background (CER/previous studies), target timelines, budget constraints, and any country preferences.
We analyze the regulatory landscape (EU MDR, UKCA, etc.) and map out standard of care pathways and reimbursement barriers in the target regions.
Direct engagement with Key Opinion Leaders (KOLs) and clinical sites to assess genuine interest, patient volumes, and competing trials.
We deliver the final, comprehensive feasibility report and enrollment forecast model during a strategic read-out session to support your regulatory discussions.
It is the process of evaluating whether a clinical investigation or PMCF study can be successfully executed before committing budget. We assess patient populations, site capabilities, competing studies, and regulatory alignment (e.g., EU MDR requirements) to recommend the best countries and sites.
We specialise in complex, high-risk devices from Class IIa to Class III. Our core therapeutic verticals are Cardiovascular, Advanced Wound Care, Orthopedics / Spine implants, Neuromodulation and Dental.
A standard feasibility project takes 4 to 5 weeks from the kick-off meeting to the final read-out session and delivery of the Enrolment Forecast Model.
While we highly recommend our proprietary, EU MDR-native MILO EDC platform for seamless and integrated data capture and inspection readiness, our clinical operations team are platform agnostic and fully adapt and work with your existing validated EDC systems if required.
Yes. While our core expertise is European (EU & UK), we have established strategic corridors and direct partnerships to conduct feasibility and operations in LATAM (Brazil, Colombia), Japan (PMDA), and India.
Notified Bodies expect robust justification for your site selection and patient population representativeness. Our data-backed feasibility reports provide the documented rationale you need to defend your PMCF or pivotal study design during Notified Body reviews.
Ready to validate your clinical strategy? Book a short call with our clinical operations team to discuss your specific device and study objectives.
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