Historical
ANSI/AAMI/ISO 13485-2003
Quality Management Systems - Medical Devices - System Requirements for Regulatory Purposes
Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer requirements and regulatory requirements applicable to medical devices.
CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]