ISO 13485

        ISO 13485 is an international standard with the name of "Medical devices - Quality management systems - Requirements". It is a quality management system requirement for organizations that design, develop, manufacture and provide medical devices.

         The purpose of ISO 13485 is to help medical device manufacturers and suppliers establish effective quality management systems to ensure that their products comply with relevant regulations and customer requirements. This standard emphasizes the safety and performance of products and requires organizations to implement a series of quality management measures throughout the entire production process, including design control, process control, data recording, auditing and verification, etc.

        By following the ISO 13485 standard, medical device manufacturers can establish a structured quality management system to improve product quality and safety and reduce defects and risks. In addition, organizations that comply with the ISO 13485 standard can enhance customer confidence, expand market competitiveness, and comply with regulatory requirements, thereby obtaining compliance certification.

        It should be noted that ISO 13485 is a quality management system standard specifically for the medical device industry and is different from the ISO 9001 quality management system standard. ISO 13485 focuses more on the special requirements and regulatory requirements of medical devices, and provides guidance more specific to the medical device industry on related design and development, monitoring, verification and verification processes.  

1. Participants will gain an in-depth understanding of the content and importance of the ISO 13485 standard.
2. Students can establish, implement and maintain a medical device quality management system (MD QMS) to ensure the quality and compliance of medical devices.
3. Plan and execute quality management system audits: Participants can plan and execute MD QMS audit activities according to relevant audit standards.
4. Understand the requirements of medical device regulatory agencies: Participants understand the requirements of medical device regulatory agencies for medical device quality management systems (MD QMS).

        After completing the ISO 13485 course, students will have the capabilities of ISO 13485 standards and MD QMS, and be able to apply these knowledge and skills to establish, implement and improve quality management system audits to ensure the high quality and compliance of medical devices.