Former Notified Body reviewers, practising clinicians, clinical operations leaders, medical writers and data experts supporting Class IIb and Class III medical devices from evidence strategy through study delivery and regulatory review.
Successful medical device programmes require more than regulatory knowledge. They require people who understand how reviewers assess clinical evidence, how clinicians evaluate meaningful outcomes and how clinical studies are delivered across sites, countries and data systems.
At Eclevar MedTech, senior experts remain involved throughout the programme. They define the strategy, challenge key assumptions, review critical deliverables and provide clear escalation routes to the operational teams responsible for delivery.
Select a capability to filter the leadership profiles below.
The leaders responsible for Eclevar’s strategy, governance, therapeutic direction and international development.
Founder and Chief Executive Officer
Chems founded Eclevar MedTech to give medical device manufacturers specialised clinical and regulatory support built around scientific quality, senior accountability and practical execution. He oversees strategic development, international partnerships and sponsor relationships, and makes sure complex programmes get the right therapeutic, operational and regulatory leadership.
Chief Operating Officer and Head of Cardiovascular · Senior Consultant Surgeon
Cardiac surgeon and former TÜV SÜD Team Leader and Senior Clinical Reviewer. Having assessed hundreds of cardiovascular technologies, he helps manufacturers anticipate the questions that arise during Notified Body review and build evidence strategies that hold up scientifically, clinically and operationally.
Chief Financial Officer
Christophe oversees financial governance, commercial planning and sustainable international growth. He supports the executive team in structuring complex client engagements and keeps clinical programmes backed by transparent, reliable commercial frameworks.
Chief Data Officer
Sébastien leads data strategy, data management and digital clinical systems. He owns the frameworks used to collect, standardise and analyse clinical data so that datasets stay traceable, interpretable and ready for scientific and regulatory use.
Head of Quality and Compliance
Jimmy runs quality management and regulatory compliance across the group. He owns the ISO 13485 certified quality system, keeps every study and every dataset audit ready from the first day, and provides the quality oversight that sits above all clinical programmes.
Appointment effective September 2026
Our incoming Managing Director joins in September 2026 to lead Eclevar MedTech’s German organisation, covering commercial development, sponsor and institutional relationships across the DACH region. The role brings manufacturer-side medical device experience to the sponsor conversation and connects German programmes to the group’s European clinical, data and regulatory teams.
No leaders in this section match the selected capability.
Therapeutic strategy, clinical interpretation and the scientific writing that carries the evidence.
Chief Medical Officer, Orthopaedics and Spine · Senior Consultant Surgeon
NHS orthopaedic surgeon and former TÜV SÜD Senior Reviewer specialising in Class III implantable devices. He combines current surgical practice with first-hand knowledge of Notified Body expectations, and has worked as a Principal Investigator in robotic surgery research.
Head of Medical Writing
Pierre-Marie leads the medical writing function with more than ten years on EU MDR clinical evidence programmes. He specialises in Clinical Evaluation Reports, PMCF documentation, clinical investigation reports and responses to complex Notified Body deficiencies.
No leaders in this section match the selected capability.
Clinical strategy creates value only when it can be delivered consistently across sites, countries and data systems. These are the named leaders who run start-up, monitoring, data management and project execution.
Head of Clinical Operations, DACH region
Susanne runs clinical operations across Germany, Austria and Switzerland: study start-up, site delivery, monitoring strategy and operational quality, on Class I to III devices in multiple therapeutic areas.
US Clinical Operations
This role plans and supports medical device clinical programs in the United States, aligning study execution with US site expectations while staying coordinated with Eclevar’s central therapeutic, data and project leadership.
Project Delivery Lead, France and United Kingdom
Charline coordinates French and UK clinical programmes from mobilisation through close-out, across sponsor teams, clinical operations, data management, medical writing and external vendors.
Senior Data Manager, Cardiovascular
Mathilde runs data management for cardiovascular clinical investigations and registries, from eCRF design and data review through query management to database lock preparation.
UK Site Delivery Lead and Lead CRA
Scott leads monitoring and site delivery across the United Kingdom: feasibility, activation, monitoring, recruitment oversight and escalation with UK investigators.
Lead CRA, Italy
Teresa Cosentino leads clinical monitoring and site delivery in Italy, from site qualification and activation through monitoring and close-out, in close contact with investigators and central study teams.
No leaders in this section match the selected capability.
Sponsors always know who is responsible locally and who to escalate to centrally.
The people you are most likely to speak to first, before the therapeutic and operational leaders join the discussion.
Business Development Lead
Karina is the first point of contact for manufacturers approaching Eclevar. She qualifies incoming programmes, sets up scoping calls with the relevant therapeutic and operational leaders, and follows the sponsor relationship through proposal and contracting.
Head of Marketing
Sullivan Benedetto leads marketing, digital presence and scientific communication across Europe, the US and Asia, turning the expertise of the clinical and regulatory leads into webinars, whitepapers, regulatory explainers and the group’s multilingual website.
No leaders in this section match the selected capability.
Five points where named senior experts are involved, from first scoping call to reviewer response.
The relevant therapeutic, operational and data leaders review the device, evidence position, development stage and regulatory objective.
Senior experts define or challenge the clinical strategy, study model, endpoints, evidence gaps and key regulatory assumptions.
Named project, clinical operations and data leaders manage day-to-day execution with defined responsibilities and escalation routes.
Critical deliverables receive specialist review before sponsor approval, database lock, final reporting or regulatory submission.
Clinical, therapeutic and medical writing leaders support responses to reviewer questions and evidence deficiencies.
This integrated model reduces the gaps that appear when strategy, clinical delivery, data management and regulatory writing are managed by disconnected providers.
Programme examples are described without sponsor names. Named references and testimonials are available on request.
600+ patients enrolling · 8 UK cardiac centres · evidence aligned to NICE requirements
Clinical evidence strategy, study planning and senior cardiovascular oversight for a transcatheter valve technology.
Dr Mark Da Costa and the cardiovascular delivery team
Explore cardiovascular capabilities →Class III implantable devices · CER and PMCF strategy · former Notified Body review experience
Clinical and post-market strategy built by a practising orthopaedic surgeon who previously assessed these device families for a Notified Body.
Dr Nikhil Khadabadi
Explore orthopaedics and spine →Randomised PMCF · 160 patients · 14 sites across 5 European countries
Regional coordination with named operational and monitoring leadership, and all authority and ethics submissions prepared in house.
Susanne Höfer, Scott Roe, Charline Petitdemange and Teresa Cosentino
Explore European clinical operations →Eclevar MedTech is expanding its digital clinical capabilities. This role is open and being recruited now, alongside the data leadership already in place.
Leads the user experience, workflow design and functional evolution of Eclevar’s EDC and eCOA solutions, working with clinical operations, data management, quality, technology, sites and patients so that digital products support real clinical workflows.
The relevant senior leaders participate according to the programme’s therapeutic area, complexity and scope. Day-to-day delivery is managed by named project and functional specialists, with defined senior oversight, quality reviews and escalation routes.
Yes. Eclevar’s leadership includes former TÜV SÜD Senior Reviewers with experience in cardiovascular, orthopaedic, spinal and Class III implantable medical devices.
Yes. Eclevar combines central programme leadership with regional clinical operations and monitoring capabilities, including named leadership for Germany and the DACH region, France, the United Kingdom and Italy.
Yes. Eclevar integrates therapeutic strategy, clinical operations, data management, biostatistics and medical writing within one programme governance model.
Send us a device description, therapeutic area, development stage and current evidence challenge. Business development coordinates the first call and brings in the appropriate senior and operational leaders.
Former positions are stated for biographical context only. Eclevar MedTech is independent and is not affiliated with or endorsed by TÜV SÜD. TÜV SÜD is a registered trademark of its respective owner.
Tell us about your device, evidence challenge and target market. We bring the relevant clinical, operational, data and regulatory experts into the first discussion.
Class IIb and Class III programmes, EU MDR and beyond.
Discuss your programme