This specialty cultivates moral, intellectual, physical and aesthetic development, with good professional ethics and humanistic literacy, mastering the medical device regulatory laws and regulations and quality standards, with the necessary theory and professional skills of medical device supervision, engaged in medical device safety supervision, registration management, quality management and other work, and can be in the government supervision and management of the grass-roots departments engaged in the administration and supervision of the quality of high-quality and practical talents.
Medical Device Maintenance and Management Professional Employment Direction
Mainly for the medical device industry, in the medical device production, operation, technical service enterprises, medical institutions and regulatory agencies, engaged in quality and safety supervision, quality control management, registration and certification management, administrative licensing matters for work. The company's main goal is to provide the best possible service to the customers in the field of medical devices.
The main professional ability of medical device maintenance and management
1. Master the writing skills of regulatory instruments, with the ability to fill out and produce the commonly used instruments for the supervision of medical devices;
2. Master the process of registration of medical devices, with the ability to collect information, fill out the materials in the process of registration of products, the production of documents, and the ability to communicate with the organization;
3. Master the quality management system, with the ability to establish and maintain a quality management system. Knowledge of quality management system, with the ability to establish and maintain quality management system;
4. Understanding of medical device laws and regulations, mastering the response or implementation of administrative licenses, penalties, reconsideration and litigation of the basic legal skills.