TheraGenesis - A unique european medical device development CRO!

Distinguishing Features

  • Established in 1995, TheraGenesis has partnered with medical device manufacturers and entrepreneurs, creating value and realizing objectives.
  • Decades of clinical and regulatory experience in Europe and the United States,
  • Competence in the development of medical device and in-vitro diagnostic technologies, as well as pharmaceutical, biotechnology, biologic therapies and nutritional products,
  • Broad spectrum experience in virtually all areas of medicine,
  • Geographic scope extending to all European countries.

Service Scope

  • Technology Assessment vis-a-vis regulatory framework and requirements
  • Conformity Assessment management
  • Definition and optimization of clinical development strategy
  • Clinical study realization
  • Authorized Representative mandate
Current & Past Clients
AMED AMS Apotex Argomed Atritech AVITA BCSI Calypso cardiogenesis cibiem 170x26 Conjuchem Convatec covidien 244x90 Cryocor CSI ekos Endocross EV3_196x90 First_Circle Genzyme Glaukos GMP HK_surgical Icecure Intuitive IonMed Logo_ISS Logo_KOWA medcool1 Medtronic Logo_Microport Microvena Myocor Nexus Nonin Olympus Logo_Orsan Polyheal Rox sentreheart SeptRX ST_jude Logo_Tendyne Logo_Teva TriReme VSI
Introduction
Dear Colleague,
      We welcome you to this website and appreciate your interest in TheraGenesis GmbH. The content of this website was concieved and developed with two purposes in mind:
      • The provision of infomation within the tab "Company" addressing our Services, Expertise, Client Portfolio, Accomplishments, Company Leadership, our Partners and Employment Opportunities. Here, attention was applied to provide you with this information at a single page level with concise simplicity.
      •  As a founding member of the Association of Clinical Research Professionals, periodic Board membership, as well as Chairmanship and also many year membership on the European Steering Committee of Regulatory Affairs Professional Society, I have been committed to education for professionals within our industry. Within the tab "Resources," you will find operationally valuable multiple page level professional analysis of regulatory and clinical themes including Competent Authorities, Notified Bodies, Harmonized Standards, European Clinical Research Centers and Ethics Committees and a structured approach to understanding the European regulations for Medical Devices, Active Implantable Medical Devices, In-Vitro Diagnostic Devices, Advanced Therapies and Pharmaceuticals.
I acknowledge you for your contribution to the development of forefront innovations in medical technology, bringing valuable therapies and diagnostics to patients worldwide. We welcome a dialog with you to explore the contribution that we may be for your product development efforts. Thank you and best regards!
    Erik Hesse
      Managing Director

OUR MISSION

"Piloting the clinical and regulatory development and market introduction of innovative medical devices in Europe and beyond!"

OUR GOAL

"Extend the capabilities and expertise of our customers!"

OUR COMMITMENT

"Integrity, quality, partnership and teamwork!"

OUR INSPIRATION

"Making innovative new therapies and diagnostic products available to patients worldwide!"

CONTACT

TERMS OF USE
Copyright © 2017
TheraGenesis™ GmbH
Bahnhofstraße 5
D-55276 Oppenheim
Germany
Tel: +49 151 50 64 03 14
erik.hesse(at)theragenesis.com