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.

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