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.
Book a call
Schedule a conversation with our team.
Choose a time that works for you and book a 30-minute call directly.
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 registriesTell us about your project
Fill in the form and the right lead replies by email. All fields are required.
Company 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 .
London Registered office, United Kingdom
Tokyo Asia Pacific
Dublin hosts our EU representation. 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.