Eclevar MedTech is a biostatistics CRO for medical devices in Europe. Statistical Analysis Plans, sample size and power, adaptive and Bayesian design, CDISC SDTM and ADaM, and validated programming, written in the language Notified Body reviewers expect.
Thirty years in clinical biometry and the architect of the MILO EDC, built to 21 CFR Part 11 standards. He leads Statistical Analysis Plans, sample size strategy and CDISC delivery for medical device trials.
Platinum Award, xShare Open Call for Clinical Research, organised by EUCROF and co-funded by the European Union. Amsterdam, 2 February 2026.
From the first sample size question to the final dataset, biometry led by people who know what a reviewer needs to see.
From protocol to clinical study report, the statistical chain stays under a single biometry lead.
Statistics trusted by global medical device manufacturers
Programmes delivered for manufacturers in wound care, neuro, renal, dental and cardiovascular devices.
Statistical design that gets more out of every patient. Eclevar manages the upcoming PMCF studies on chronic diabetic foot ulcer devices for RegenLab, a tissue-engineering specialist present in 160 countries.
"Eclevar, with its tailor-made approach and advanced MILO Studio platform, represents a major strategic asset."Antoine Turzi, CEO, RegenLab
Restructured Japanese clinical evidence and analysis into the rigour European Notified Body reviewers expect for the EEG-1200K.
"Eclevar shared their expertise so we could create documentation perfectly adapted to our needs. The team responded promptly and flexibly."Product Manager, Nihon Kohden
Clinical evaluation and post-market evidence generation for advanced dental and restorative technologies.
A multi-centre reimbursement clinical trial delivered in the UK.
Most statistics suppliers hand back numbers. We hand back a defence your Notified Body will accept.
Templates in, tables out. Context optional.
Your smart way to compliance, with the methods in the open.
Statistics do not stand alone. Our biometry lead works beside clinicians and former reviewers who define the endpoints that matter.
Thirty years in biometry and architect of the MILO EDC, leading SAPs, sample size and CDISC delivery to 21 CFR Part 11.
Cardiac surgeon and former Notified Body reviewer who frames cardiovascular endpoints for Class III devices.
Connects statistical results to Clinical Evaluation Reports under MEDDEV 2.7/1 Rev 4 and EU MDR.
Former senior reviewer at TÜV SÜD, defining endpoints for Class III orthopedic and spine implants.
Keeps the data clean at source through site qualification and ISO 14155:2026 oversight.
On-site and remote monitoring that protects data quality across European investigation sites.
Meet the full leadership team, including founder and CEO Chems Hachani
Biostatistics is delivered centrally from a single accountable team, working on data from EU MDR clinical investigations and PMCF studies across the core European markets. Dedicated regulatory corridors connect your device to Japan and India, and partner reach extends to 160 countries.
Send your protocol synopsis or device claims and talk methods with a senior biostatistician who has seen your device class from the other side of the review.
Talk to a biostatistician