Elemaster Shanghai, the company of Elemaster able to serve its customers directly in the Chinese market thanks to the production plant located in Shanghai, announced today that the company has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. This certification is a requirement for regulatory purposes and it is an international standard that outlines a quality management system specific to the medical devices industry.

It is indeed a great pleasure to affirm that Elemaster Shanghai aligns with the multi-year skills and with the expertise gained by the Elemaster Group, and it is ready to serve Customers operating in the medical sector, both to satisfy local needs of the Chinese market and to serve the global demand” says Valentina Cogliati, President and CEO of Elemaster Group “The entire production and design process is now ISO 13485:2016 certified in Shanghai plant too, and this is the best internationally recognized model to demonstrate that we have successfully complied with the laws and regulations of the medical devices industry”. “An important milestone for our company which reflects the focus we have on commitment to safety and providing a high-quality product” commented Roberto Corti, General Manager of Elemaster Shanghai “I would like to congratulate our COO and the local team for the excellent result achieved” he added “always remembering to keep a continuous improvement mindset!”

Elemaster Shanghai Medical Certification