Recently, SUNGO assisted a domestic medical device manufacturer to carry out guidance on MDSAP system, helping the manufacturer to establish system management in line with MDSAP requirements, providing training on regulation and guidance on audit for the manufacturer.
In the process of this assistance, the enterprise expressed a high recognition for the professionalism of SUNGO consultants, and expressed the gratitude to SUNGO consultants for still insisting on providing on-site guidance for enterprises during the epidemic period.
Finally, after two stages of intense audit, SUNGO finally assisted the enterprise to successfully pass the audit and obtain the MDSAP certificate.
This signifies that, with SUNGO's assistance, the manufacturer's products are designed, manufactured and served in compliance with the requirements of ISO 13485:2016 and the medical device regulations in five countries (Australia, Brazil, Canada, the United States and Japan).
This will effectively improve the quality management level of the company's medical devices, and play a positive role in promoting the development of the company, especially the market development of the medical devices industry and its entry into the international market.
SUNGO is committed to becoming a medical device compliance expert around you, providing customers with compliance services for market access in various countries. We have been working hard!
The services offered by SUNGO
1) MDSAP special training service;
2) Guide enterprises to establish quality management system in line with MDSAP requirements;
3) Analyze the gap between the existing system and the regulatory requirements;
4) Simulate the audit to help enterprises identify weak links;
5) Accompany the on-site audit;
6) Guide enterprises to carry out the rectification and rectification reply after the review.