ISO 13485:2016 – Medical Devices Quality Management Systems (MDQMS)
What is ISO 13485? ISO 13485:2016 is the global standard for Medical Devices Quality Management Systems (MDQMS). It defines the requirements for organizations involved in the manufacturing, design, and distribution of medical devices to consistently meet customer and regulatory requirements. ISO 13485 is customized to the medical device industry, with a strong focus on risk […]
