Contract Manufacturing

Contract Manufacturing and R&D of Prosthetic Heart Valves

Tissue Preparation

  • Sourcing of tissue from slaughterhouses inside and outside the EU (including GBR1 countries) – equine, bovine or porcine
  • Design and development of the methods for tissue fixation, storage, and sterilization
  • Development and implementation of anticalcification and detoxification treatment
  • Laser cutting

Development of Heart Valves

  • Design of surgical and transcather heart valves
  • Prototyping of heart valves
  • Hydrodynamics and durability testing
  • Manufacturing of heart valves ready for animal testing
  • Design and development of methods for heart valve sterilization and storage

Laboratory Services

  • Sterility testing
  • Biocompatibility testing
  • Biomechanical (tensile) testing

Clean Room

Quality Management

  • Implementation of quality controls
  • Preparation of work instructions
  • Development of protocols and records
Contract manufacturing is in the scope of our Quality Management System according to EN ISO 13485:2016