Our Services

• Process development for biological tissues

 

• Quality management (ISO 13485)

 

• Regulatory support (MDR, FDA)

 

• Risk management, sourcing, collection, and handling (ISO 22442-1&2)

 

• Verification and validation (V&V) planning and testing:

• Mechanical testing
• (Bio)chemical characterization
• Histological characterization
• Biocompatibility testing (ISO 10993 series)
• Development and validation of chemical sterilization procedures

         (ISO 11737 series, ISO 11135, ISO 14160) 

• Viral & TSE safety (ISO 22442-3, EDQM)