ACD completes ISO 13485 recertification

ISO 13485:2012 was published in January 2012 and supersedes ISO 13485:2003. The new version of the standard was developed to harmonize with the EU Medical Device Directives 90/385/EEC, 93/42/EEC and 98/79/EC. It provides assurance to medical device end-users outside of the United States and assurance of compliance to the European legislation. The ISO 13485 standard supplements the ISO 9001 standard and is specific to medical device quality systems. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions that are critical to the medical electronics device industry.