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