The ISO13485 medical device special standard has played a positive role in promoting GMP certification for medical devices. Drawing on the relevant content of GM P for medical devices in developed countries, different production quality management standards are proposed for different levels of medical device risk, achieving overall planning, clear standards, differentiated treatment, and segmented implementation.
3. Why implement ISO13485?
To strengthen the management of medical devices and enhance enterprise quality control,
Ensure the personal safety of patients and provide users with products of stable quality,
Meet the requirements of our users and make greater contributions to our medical device industry