LICQual ISO 13485:2016 Medical Devices Quality Management Systems
The LICQual ISO 13485:2016 Medical Devices Quality Management Systems (QMS) course offers essential training designed for professionals in the healthcare and…
ISO 13485:2016 Medical Devices Quality Management Systems
ISO 13485:2016 is an international standard that specifies the requirements for a quality management system (QMS) for medical device manufacturers. It provides a comprehensive framework for ensuring that medical devices are consistently designed, developed, and produced in compliance with regulatory and safety standards. The standard emphasizes risk management, process control, and documentation to enhance product quality, traceability, and regulatory compliance. ISO 13485:2016 helps organizations improve operational efficiency, reduce errors, and maintain high standards of quality and safety throughout the life cycle of medical devices.