Aran Biomedical’s Quality Management System is certified to EN ISO 13485:2016 for both manufacturing and the provision of design services. We are also compliant to FDA standards; 21 CFR 820 Quality System Regulation Medical Devices Good Manufacturing Practice
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 and
- 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.