Ex TUV SUD Reviewer
Chief Operating Officer (COO) & Head of Cardiovascular Department
Prof. Mark Da Costa serves as Chief Operating Officer and Head of the Cardiovascular Department at ECLEVAR MEDTECH, leading one of the most regulator-aware cardiovascular evidence teams in Europe.
A distinguished cardiothoracic surgeon with decades of high-risk operative experience, Mark combines frontline structural heart expertise with insider regulatory intelligence. Prior to joining ECLEVAR MEDTECH, he was Team Lead Cardiovascular Clinical Reviewer at TUV SUD, where he led the assessment of complex Class III cardiovascular technologies under the EU MDR.
His career bridges three domains that rarely coexist within a single leader: clinical excellence, structural heart innovation, and notified body scrutiny.
Prof. Da Costa has extensive exposure to advanced cardiovascular interventions and surgical technologies. He understands not only device mechanics, but procedural realities, anatomical challenges, and outcome variability in real-world structural heart populations.
Transcatheter Aortic Valve Implantation
Transcatheter Edge-to-Edge Repair
Left Atrial Appendage Occlusion
Transcatheter Mitral Valve Therapies
Complex valve repair and replacement systems
High-risk implantable cardiovascular devices
This clinical depth ensures that ECLEVAR designs evidence strategies that reflect procedural reality, not theoretical endpoints.
As former Team Lead Cardiovascular Reviewer at TUV SUD, Prof. Da Costa evaluated and challenged clinical evidence submitted for structural heart platforms, valve systems, implantable cardiovascular devices, and combination technologies.
How Notified Bodies interpret structural heart data and where benefit-risk justifications fail.
How performance endpoints must be framed to withstand regulatory scrutiny.
How to defend equivalence claims under EU MDR requirements.
How to structure PMCF for long-term implantable technologies.
How to anticipate regulatory scrutiny before submission — not after.
This is strategic regulatory foresight, not post-hoc correction.
As COO and Head of Cardiovascular, Prof. Da Costa oversees the full spectrum of cardiovascular clinical strategy and evidence generation.
Cardiovascular and structural heart clinical strategy development.
MDR-aligned Clinical Evaluation Reports for cardiovascular devices.
PMCF and long-term follow-up architecture for implantable technologies.
Early feasibility and pivotal trial design for cardiovascular devices.
Global evidence alignment across EU, UK, Japan, and US regulatory frameworks.
KOL engagement and scientific board structuring for cardiovascular programs.
