1. the company's business license and certificate of qualification.
2. Manufacturing license and registration certificate of medical devices.
3. The company's quality management system documents, including quality manual, program documents, operating instructions, etc..
4. Production and quality control records of the company, including production records, inspection records, records of non-conforming products, etc.
5.
5. The company's training program and training records, including new employee orientation training, product knowledge training, quality awareness training.
6. The company's production equipment and inspection equipment list, including the name of the equipment, model, specifications, manufacturer, use of state.
7. A list of the company's production and inspection sites, including production workshops, warehouses, laboratories and other places of the floor plan and layout.
8. The company's production and inspection flow chart, including the flow chart of the entire process from the purchase of raw materials to the delivery of products.
9. A list of the company's suppliers and customers, including the names, addresses, and contact information of suppliers and customers.
10. production and sales data of the company, including recent production and sales volume, sales, etc.
11. the company's quality objectives and quality plans, including future quality objectives and quality plans.
12. the company's product registration certificate and production license related documents, including application documents, review reports, etc..
These are just some of the things that may need to be prepared, and what exactly needs to be prepared should be determined according to the requirements of the FDA and the actual situation of the company.