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Astrodyne TDI Certifications
Astrodyne Production facilities are certified to Quality Management Standard ISO 9001:2008. In addition, various faculties have additional certifications to meet the needs of the clients and their end product.
ISO 13485:2008 specifies requirements for a quality management system with the focus on the ability to provide medical devices that consistently meet customer and regulatory requirements which are applicable to medical devices. As a result, it includes some particular requirements for medical devices and excludes some of the nutriments of ISO 9001 that are not appropriate as regulatory requirements. As a result, each location with a ISO 13485 certification also maintains a separate ISO 9001 certificate.