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
ISO 13485:2016 is an international standard for quality management systems (QMS) specifically designed for the medical device industry. It provides a framework for manufacturers to ensure their products consistently meet regulatory requirements and customer expectations for safety, effectiveness, and quality. ISO 13485:2016 focuses on key aspects such as risk management, process control, and documentation, helping organizations maintain compliance with global regulations and improve the quality of medical devices throughout their life cycle. Adopting this standard enhances an organization’s ability to produce safe, high-quality medical devices while streamlining regulatory approval processes.