Platinum Award · xShare & EUCROF 2026

Experts from both sides of the table.

The leadership of Eclevar MedTech, a medical device CRO in Europe: a former Notified Body reviewer, senior clinicians, medical writers and biostatisticians with direct EU MDR Class III submission experience. The people on this page are the people on your project.

Book a free scoping call › Meet the team

1

Former Notified Body reviewer

30 yrs

Biometry experience (CDO)

4

Offices: London, Paris, Dublin, Tokyo

Class III

Direct submission experience

Eclevar MedTech receiving the Platinum Award at the xShare and EUCROF Awards in Amsterdam

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

Trusted by leading medical device teams

The experts behind the evidence.

Leadership & clinical strategy

Management Team

Senior experts who stay close to delivery. Your project is led by the names below, not handed to a junior account team.

Chems Hachani

Chems Hachani

Founder & CEO

15+yrs

in clinical trials, PMCF & medical device evidence

›Built Eclevar’s therapeutic departments
›Piloted MILO Studio
›Opened global corridors from the EU to Japan (PMDA)

Dr Mark DaCosta

Dr Mark DaCosta

COO · CMO Cardiovascular

25+yrs

in cardiac surgery & cardiovascular device evaluation

›Cardiac surgeon & former TÜV SÜD Senior Reviewer
›Assessed 400+ cardiovascular devices in Europe
›Leads TAVI, structural heart, coronary & guidewire programmes

Susanne Höfer

Susanne Höfer

Head of Cardiovascular Clinical Operations · DACH

19+yrs

in international cardiovascular & interventional research

›Programmes covering ~200 sites & ~3,000 patients
›Cath-lab support, investigator training & KOL collaboration
›Oversees study delivery across the DACH region

Dr Nikhil Khadabadi

Dr Nikhil Khadabadi

CMO · Orthopaedics & Spine · NHS surgeon

20+yrs

in orthopaedic surgery & Class III device evaluation

›Assesses Class III orthopaedic & spinal evidence under EU MDR
›Former Principal Investigator, Stryker robotic surgery trial
›Leads CERs, PMCF, investigations & registries

Pierre-Marie Boutanquoi

Pierre-Marie Boutanquoi

Head of Medical Writing

10+yrs

in EU MDR clinical evidence & scientific writing

›Expert in CER, PMCF documentation & MEDDEV 2.7/1
›Resolves Notified Body deficiencies (BSI, TÜV SÜD)
›Builds Article 61 strategies & traceability matrices

Sébastien Meier Piantanida

Sébastien Meier Piantanida

Chief Data Officer · Head of Biometry

30yrs

in biometry, EDC & clinical data systems

›Lead architect of MILO Studio
›Co-author of the EU MDR biometric activities framework
›21 CFR Part 11 compliance & FDA/EMA inspection readiness

Jimmy Andrew Hayek

Jimmy Andrew Hayek

Head of Quality & Compliance

10+yrs

in quality management & regulatory compliance

›Supervises the ISO 13485:2016 certified QMS
›Every study & dataset audit-ready from day one
›Quality oversight across all programmes

Karina Schönborn

Karina Schönborn

Head of Partnerships

10+yrs

in partnerships & clinical programme scoping

›Scopes new programmes with manufacturers
›Connects each project to the right Eclevar experts
›Represents the team at European conferences

Charline Petitdemange

Charline Petitdemange

Clinical Operations Director

10+yrs

in European medical device clinical research

›Leads clinical investigations & PMCF delivery across Europe
›Site management & operational excellence
›Full compliance with ISO 14155:2026 & EU MDR

News & events

Where to meet us in 2026.

Paris · 19 to 22 May 2026

Meet us at EuroPCR 2026

The Eclevar team, including our former Notified Body expert, on what cardiovascular trials need to satisfy Notified Body review.

Book a meeting ›

Frankfurt · 3 June 2026 · Speaker panel

Impact of MDR on device innovation

Dr Mark DaCosta, COO and former Notified Body expert, joins the CSI Frankfurt speaker panel on EU MDR and the introduction of new devices.

See the session ›

Clinical trial forecasting

From an 8-week RFP to a 30-minute roadmap

Our award-winning platform reads a protocol and returns three costed scenarios (swift, base, conservative) plus a recruitment forecast.

Explore the platform ›

Frequently asked

Questions sponsors ask about the team.

Does Eclevar really have a former Notified Body reviewer on the team?

Yes. Dr Mark DaCosta, COO and CMO Cardiovascular, is a cardiac surgeon and former senior reviewer at a Notified Body (TÜV SÜD). He leads regulatory strategy with first-hand experience of Notified Body questioning cycles.

Who will actually work on my project?

The people on this page. Eclevar deliberately keeps senior experts close to delivery: clinical strategy, medical writing, biometry and operations are led by the executives themselves, not handed to junior account teams.

Who is my first point of contact?

Karina Schönborn, Head of Partnerships, is the first contact for scoping calls and new partnerships. Write to clientcare@eclevar.com and she will set up a call with the right experts for your device.

Can the team handle Class III and implantable devices?

Yes. The team has direct EU MDR Class III experience across cardiovascular, orthopaedic and implantable devices, including technical file structuring, CER methodology, PMCF programmes and Notified Body Q&A cycles.

Talk to the experts

Put a former Notified Body reviewer on your side of the table.

Tell us about your device. Karina will set up a scoping call with the right experts from this page.

Book a free scoping call ›