End-to-End Clinical Data Management for MedTech

End-to-end clinical data management for medical devices, built for EU MDR.

Electronic data capture, query management, biostatistics, medical coding and database lock for clinical investigations and PMCF studies across France, the UK and Germany. Every record managed to 21 CFR Part 11 and GDPR, so your data holds up to Notified Body review.

Top prize at the xShare Open Call for Clinical Research, organised by EUCROF and co‑funded by the European Union, awarded to Eclevar MedTech and its Milo Health platform.

Platinum Award · xShare Open Call for Clinical Research, organised by EUCROF and co‑funded by the European Union. Amsterdam, 2 February 2026.

Your clinical data, in the hands of senior specialists.

Data management is only as good as the people who design the eCRF and defend the database lock. Two of them lead every Eclevar data programme.

Chief Data Officer · Biometry lead

Chief Data Officer with more than 30 years in biometry, leading clinical data architecture, statistics and database lock across Eclevar's medical device studies. He owns the data model end to end, from eCRF and database design through edit‑check strategy, statistical analysis plans and CDISC and SDTM datasets, to the locked, submission‑ready database. His experience spans structural heart, orthopedics and complex Class III investigations, where endpoint definitions and data quality decide whether a study survives Notified Body review. For MedTech sponsors, he is the guarantee that statistics and regulatory review both start from clean, defensible numbers.

Senior Clinical Data Manager

Senior Clinical Data Manager with more than 10 years in clinical data management, including over five years at the Cardiovascular European Research Center (CERC), where she led the data management team on cardiovascular device studies. She has designed and validated eCRFs across multiple EDC platforms (Cleanweb, Clinical Studio, Castor), with deep expertise in data validation, consistency‑check programming (SAS, R) and database lock for complex clinical investigations. A biomedical engineer (ISIFC) with a Master's in biomedical information processing, she is a major asset for MedTech manufacturers facing the clinical‑data requirements of the European MDR.

Compliant with EU MDR 2017/745 ISO 14155:2026 ISO 13485 21 CFR Part 11 GDPR

What you need managed

Tell us what your data needs

Whatever brings a MedTech sponsor to clinical data management for medical devices, Eclevar maps directly to the brief: clean data capture, a statistics and coding partner, or audit‑ready compliance.

Electronic data capture and eCRF

Database and eCRF design, electronic data capture, built‑in edit checks and query management, so clean data is built in from first patient in.

Reconciliation, medical coding, statistical analysis plans, CDISC and SDTM datasets and database lock, led by a dedicated data and biometry team.

Validated systems with full audit trails, access control and electronic signatures, aligned to 21 CFR Part 11 and GDPR, so records hold up to Notified Body review.

Clinical data that is clean from day one

Most data problems are discovered at database lock, when they are expensive to fix. Eclevar changes the order of operations, cleaning as it captures.

Traditional approach

The usual experience

• Paper or email capture, fragile audit trail
• Errors found late, at database lock
• Opaque query cycles with no clear status
• Manual coding and inconsistent terminology
• Data not structured for submission

vs

Eclevar

Your smart way to compliance

• Validated electronic capture, full audit trail
• Edit checks catch errors at the point of entry
• MedDRA and WHODrug medical coding
• CDISC and SDTM datasets, submission ready
• 21 CFR Part 11 and GDPR built in by design

Across therapeutic areas

Data expertise where it matters most

Five focused franchises, each with clinical, regulatory and data leads who know the device class and its endpoints inside out.

Cardiology

Structural heart and Class III, our lead franchise.

Orthopedics

Spine and implants, built by a former NB reviewer.

Neuromodulation and neuro-implants.

Wound care

Advanced wound care and regenerative devices.

Programmes we manage

Class IIa EEG · Japan to EU MDR

Documentation logic for Notified Bodies

Restructuring Japanese clinical documentation into the language and rigour European Notified Body reviewers expect, for the EEG-1200K. The team responded promptly and flexibly, reports the Nihon Kohden product manager.

Shofu Inc.

Dedicated clinical evaluation and post‑market evidence generation for advanced dental and rest