ISO 10993-Biological evaluation of medical devices

ISO-10993-18

ISO 10993 Part-1 to 23-Biological evaluation of medical devices ISO 10993-Biological evaluation of medical devices is a series of international standards that outline the biological evaluation of medical devices. These standards are published by the ISO and are used to assess the potential risks associated with the use of medical devices on living organisms. The […]

ISO 13485:2016

ISO 13485:2016-Medical devices — Quality management systems

What is ISO 13485:2016-Medical devices — Quality management systems? ISO 13485:2016 is an international standard for Quality Management Systems (QMS) specific to the medical device industry. It provides a framework for organizations involved in the design, development, production, installation, and servicing of medical devices to establish and maintain an effective quality management system. ISO 13485 […]