ISO 13485 Standard for Medical Devices!
ISO 13485–”Medical devices–Quality management systems–Requirements for regulatory purposes” is the standard for organizations engaged in the manufacture of medical devices and components.
In the field of medical products, devices, and components, regulatory requirements and customer expectations are demanding. Throughout the world, manufacturers and their suppliers are expected to comply with the highest standards and regulations. ISO 13485–”Medical devices–Quality management systems–Requirements for regulatory purposes” is the standard for organizations engaged in the manufacture of medical devices and components, according to the most recent survey by the International Organization for Standardization. As we migrate toward implementation of this process expected early in the 4th quarter of 2009, we will keep you posted as to the exact date of audit and implementation.
