Meditrial Team

Executive Management

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Monica Tocchi

MD, PhD
Founder,
Chief Medical Officer

  • Meditrial Europe Ltd.
    Banhofstrasse 23 CH-6300, Zug
    Ph. +41 41 7100524
  • Meditrial USA Inc.
    866 United Nations Plaza - New York, NY 10017
    Ph. +1 646 933 1025 – Fax. +1 646 933 1025
  • I founded Meditrial because I saw an opportunity to help create more effective collaboration between the medical community, the healthcare industry and regulators. Ultimately, the quality of patient care depends not only on the doctor-patient connection, but on countless other relationships and joint efforts that exist behind the scenes to synergically enable medical progress.
Monica Tocchi, MD, PhD

With 20+ years of expertise in clinical care, research and regulatory compliance, Dr. Tocchi is recognized for her pivotal role in leading medtech firms from strategic planning to approvals for clinical trials and market entry. Her daily work is driven by a single goal: making it easier for effective new therapies to reach the patients. She actively contributes to the development of new regulations and standards (ISO, AAMI) and is committed to education and knowledge sharing in the medical and academic community through lectures and training programs. She drives Meditrial’s strategic directives for growth, innovation and alliances.

Education

  • 1991 Medical Doctor degree with honors, La Sapienza University, Rome, Italy
  • 1991 Medical Practice License, National Physicians Society, ltaly
  • 1995 Specialist Degree in Cardiology with honors, La Sapienza University of Rome, ltaly
  • 1998 U.S. Medical Licensing Certification (USMLE)
  • 2000 Ph.D. in Cardiovascular Pathophysiology, with honors, La Sapienza University, Rome, ltaly

Languages English, Italian

Achievements

  • Dr. Tocchi is an expert active in the development of European and U.S. regulations.
  • She is a member of the ISO (international Standardization Organization) and AAMI (Association for the Advancement of Medical Instrumentation) and contributes as an expert in the working groups that develop the standards on clinical trials for medical devices (ISO 14155) , cardiac valve replacement and repair devices (ISO 5840 and ISO 5910) and a new standard on cardiac occluders.

Innovative Enterprises

2008-Today Meditrial Group
Founder and Chief Medical Officer
  • Meditrial Srl (Rome) established 2008 Meditrial Europe CH (Zurich) established 2009 Meditrial Gmbh (Berlin) established 2013 Meditrial USA Ltd (NY) established 2015
  • Meditrial is a leading Clinical Research Organization and strategic consulting firm focused on the needs of the MedTech industry. We are proud to serve the most innovative companies in the world. Our staff is recognized by customers and investigators as expert, trustworthy and responsive. Client recognition and loyalty are an attestation of our business model – we get the job done right.

Career

2005-Present ISO/AAMI Technical Committees Expert
  • Expert in Technical Committee 194/ WG 4 for ISO 14155, Clinical Investigations of medical devices
  • Expert in Technical Committee 150/ WG 2, ISO 5840 and ISO 5910 for Heart Valves (surgical valves, transcatheter valves, cardiac valve repair devices)
  • Expert in ISO Technical Committee 150/ WG 8, standard on Cardiac Occluders
2003-2008 Medical Director, Donawa Consulting, Rome Italy
  • Responsible for complete management of international clinical trials for medical devices, working with leading companies such as Edwards Lifesciences, E-Valve (Abbot), B-Braun and many others
  • Expert witness for notified body TUV PS in lawsuit on defective cardiac valves
2000-2002 Scientific Coordinator, Cardiology Department, San Raffaele Hospital Milano, Italy
  • Pioneering research and publications in various areas
  • Elecrophysiology, with Dr. Carlo Pappone
  • Interventional Cardiology, with Prof. Antonio Colombo
  • Cardiac Surgery: Prof. Ottavio Alfieri
  • Collaboration with industry for innovative technologies such as Biosense Webster Carto System, Guidant CRT, Medtronic stents and EP devices, Impulse Dynamics Optimizer
1997-1999 Visiting scientist/professor, University of Texas Medical Branch Galveston
  • Collaboration for research studies with Prof. Marshall Runge (head of Cardiology), Prof. Barry Uretsky (director of cath lab) and Dr. Christopher deFilippi (director of echo lab)
  • Prestigeous groundbraking publications (including JACC, JAMA and others)

Groundbreaking Studies

Publications and presentations

Studies published in peer-reviewed Journals Textbooks chapters and invited articles:

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