Contact
Talk to the team that builds the evidence.
Former Notified Body reviewers, practising clinicians and clinical data leads. Tell us about your device and your target markets, and we will tell you what evidence the file needs before anyone asks for it.
Projects and proposals
clientcare@eclevar.comRequest a clinical strategy roadmap for your clinical evaluation and your submission.
Project brief
Tell us about your program.
Whether it is a first EU MDR submission, a Notified Body deficiency to answer or a multi-country investigation to run, a senior strategist reads every brief. You get a named contact, not a queue.
Where to start
Three ways in.
Pick the one that matches where your device is today. Each one ends with a written output, not a follow-up call.
01
Clinical strategy call
Thirty minutes with a clinical lead. We map the regulatory route for your device class and target markets, and name the evidence gaps worth closing first.
Our CRO services02
Technical file review
A gap analysis read the way an assessor reads it, by people who did the job at a Notified Body. You get the list of deficiencies before they are raised against you.
Meet the reviewers03
PMCF and registry design
Post-market plans that hold up at renewal: endpoints, data sources, sample size and the registry design that will still answer the question in five years.
PMCF and registriesCompany information
Who you are contracting with.
Eclevar MedTech is a European CRO for EU MDR regulatory affairs, PMCF clinical investigations and clinical data management, with franchises in cardiovascular, orthopedics and spine, dental and neuro.
Where we work from
ParisHeadquarters and clinical operations
Regional clinical operations across Germany, Austria and Switzerland, France, the United Kingdom, Italy and the United States. See the programs we have delivered and the US corridor for sponsors filing on both sides.