What are the regulatory inspections for medical devices? What I know is that the system of product registration assessment production license on-site inspection 13485

Registration of the system verification, the focus of this focus on the registration of the product of the various elements of the verification of the verification of registration, such as you provide the registration test test report, there are no samples of samples, your clinical trials, is not real, and will even call the patients and doctors involved in clinical trials to verify. Another thing is the inspection of the production line.

The inspection of the production license, generally there is an on-site inspection standards, this to be more comprehensive, including the personnel situation, plant warehouse facilities and equipment, training, the production process and inspection process, the company's organizational structure, the company's quality system documents, as well as some of the records of the inspection.

Daily supervision, flight inspection, special inspection, cross-checking, this informal inspection is not very comprehensive, this kind of inspection is more inclined to sampling and inspection, plant conditions, record tracing, etc.