Contract Manufacturing

Contract Manufacturing and R&D of Prosthetic Heart Valves (TAVR, TMVR, TTVR)

Our company offers the following services:

  • Sourcing of tissue from slaughterhouses inside and outside the EU (including GBR1 countries) –  equine, bovine or porcine
  • Tissue preparation
  • Design and development of the methods for tissue  fixation, storage, and sterilization
  • Design and development of the methods for heart valve sterilization and storage
  • Development and implementation of anticalcification and detoxification treatment
  • Manufacturing of heart valve prototypes
  • Manufacturing of final valves ready for animal testing
  • Sterility testing
  • Biocompatibility testing
  • Development of quality documentation (quality procedures, inspections, test plans, work instructions)
  • Contract manufacturing is in the scope of our Qualitiy Management System according to EN ISO 13485:2016