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…
Medical Devices Quality Management Systems
Medical Devices Quality Management Systems (QMS) refer to the framework of policies, processes, and procedures that medical device manufacturers must implement to ensure their products meet regulatory requirements and maintain high standards of quality and safety throughout their lifecycle. A robust QMS ensures that medical devices are consistently designed, manufactured, and tested to meet customer and regulatory standards, such as ISO 13485. This system encompasses risk management, design controls, production processes, post-market surveillance, and documentation practices, all aimed at minimizing risks and ensuring patient safety. A well-established QMS is essential for gaining regulatory approvals and maintaining compliance in highly regulated markets such as healthcare and pharmaceuticals.