TheraGenesis
  • Home
  • Company
    • Services
    • Expertise
    • Portfolio
    • Accomplishments
    • Leadership
    • Partners
    • Jobs
  • Resources
    • Competent Authorities
    • Notified Bodies
    • Harmonized Standards
    • Clinical Research Centers
    • Ethics Committees
    • Regulations
  • Contact

  • Portfolio
  • All categories
  • Biotech
  • Cardiology & Angiology
  • Dermatology
  • Gastroenterology
  • Hematology & Infectious Disease
  • IVD
  • Neurology
  • Obstetrics & Gynecology
  • Oncology
  • Ophthalmology
  • Orthopedics
  • Pharmaceutical
  • Pulmonology
  • Radiology
  • Surgery
  • Urology

We undertake clinical investigations consistent with European and FDA regulations.  Our clients have used these clinical results to their advantage to:

  • successfully support 510(k) applications to the FDA
  • negotiate clinical trial designs within the IDE approval process with the FDA
  • support PMA applications
  • obtain positive CE-Conformity Assessment
  • successfully introduce product to the European market

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