Our quality orientated systems and services ensure that products are manufactured to the highest standards while maintaining:

• Identification and traceability from concept design and development of prototypes right through to commercial manufacturing,

• Focus on risk management activities and design control activities during product development,

• Controls in the work environment to ensure product safety,

• Environmental and microbiological controls,

• Specific requirements for documentation, validation of processes and test method preparation for sterile medical devices 

• Biomaterials testing according to ASTM and ISO standards.

Good Manufacturing Practice (GMP) is integrated into every process, protocol and test method carried out by our team. 

Our ISO Class 8 / Class 100,000 cleanroom space ensures that every unit designed and manufactured meets the necessary criteria.