A&D is proud to announce that we have updated our ISO 13485 Certification to the newest edition ISO 13485:2016.
ISO 13485 is a stand-alone QMS standard, developed from the internationally recognized ISO 9001. While ISO 13485 is based on the ISO 9001, it is more stringent and requires a more thoroughly documented quality management system.
ISO 13485 provides medical device manufacturers support and direction for designing quality management systems that establish and maintain the effectiveness of their processes.
It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.