engaged in the production of medical devices, should have the following conditions:
One, should have the conditions:
1. With the production of medical devices and the production of appropriate production sites, environmental conditions, production equipment and professional and technical personnel.
2. The production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment.
3. To ensure the quality of medical devices management system.
4. With the production of medical devices compatible with the after-sales service capabilities.
5. In line with the product development, production process documentation requirements.
Two, medical device production work:
1. Participate in product realization, design and development, production and service delivery, measurement, analysis and improvement of the process planning, input and output of the above planning activities to make recommendations.
2. Responsible for the proper use and maintenance of infrastructure (buildings, process equipment) required to achieve product conformance.
3.Responsible for the management of the work environment (including human and physical factors) necessary to achieve product conformity.
4. Responsible for daily production, responsible for the ability to confirm the critical / special process, grasp the control of the six factors affecting the product quality of the process (man, machine, material, method, environment and measurement), find problems and timely feedback, take corrective action. Ensure that the production site documents are correct and complete, product marking is clear, the environment is clean and tidy, and the production order is good.
Medical device instructions, labels should have the content and the production of medical devices:
A. Medical device instructions, labels should have the content:
1. General name, model, specifications;
2. Medical device registrant, filing person, the name of the commissioned manufacturer, Address and contact information;
3. Date of manufacture, use or expiration date;
4. Product performance, main structure, scope of application;
5. Contraindications, precautions, as well as other need to warn or prompt the content;
6. Installation and use of the instructions or illustrations;
7. Maintenance and care methods, special Transportation, storage conditions, methods;
8. Product technical requirements should be marked with other content.
Two, medical device production requirements:
1. Mechanical design, medicine-related professional.
2. Familiar with medical device industry regulations and product batch conversion.
3.Strong logic and management skills, the ability to analyze abnormalities and solve problems in a timely manner; strong learning ability, work initiative, good thinking, with a strong sense of responsibility, with a strong ability to resist pressure.