ISO 13485

        ISO 13485 is an international standard entitled "Medical devices - Quality management systems - Requirements". It sets forth requirements for quality management systems for organizations that design, develop, manufacture, and supply medical devices

         The purpose of ISO 13485 is to help medical device manufacturers and suppliers establish effective quality management systems to ensure their products comply with applicable regulations and customer requirements. This standard emphasizes product safety and performance and requires organizations to implement a range of quality management measures throughout the production process, including design control, process control, record keeping, auditing, and verification

        By adhering to the ISO 13485 standard, medical device manufacturers can establish a structured quality management system, thereby improving product quality and safety and reducing defects and risks. Furthermore, organizations compliant with the ISO 13485 standard can enhance customer confidence, expand market competitiveness, and meet regulatory requirements, thus obtaining compliance certification

        It is important to note that ISO 13485 is a quality management system standard specifically for the medical device industry, and it differs from the ISO 9001 quality management system standard. ISO 13485 focuses more on the specific requirements and regulatory requirements of medical devices, and provides guidance more tailored to the medical device industry for related design, development, monitoring, verification, and validation processes 

1. Trainees will gain a deeper understanding of the content and importance of the ISO 13485 standard
2. Trainees will be able to establish, implement, and maintain a Medical Device Quality Management System (MD QMS) to ensure the quality and compliance of medical devices
3. Planning and executing quality management system audits: Trainees will be able to plan and execute MD QMS audit activities based on relevant audit standards
4. Understand the requirements of medical device regulatory agencies: Trainees will learn about the requirements of medical device regulatory agencies for medical device quality management systems (MD QMS)

        Upon completion of the ISO 13485 course, participants will acquire the skills required for ISO 13485 standards and MD QMS, and will be able to apply this knowledge and skills to establish, implement, and improve quality management system audits to ensure the high quality and compliance of medical devices