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
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