Andaman Medical, a medical device regulatory affairs consultancy for Southeast Asia, has announced it has received ISO 13485:2016 certification.

This certification is the result of implementing a vigorous quality management system which governs its consulting services.

Mourad Kholti, CEO and founder of Andaman Medical, said: “I am extremely proud of the dedication of our team in achieving ISO 13485:2016. It embodies our ethos and recognises that Andaman Medical meets the highest standards of the medical device sector which we serve. With medical device manufacturing being one of the most heavily regulated sectors, we can now demonstrate our commitment to the quality and safety of the medical devices we register and represent throughout Southeast Asia.”

ISO 13485:2016 is an internationally recognised standard of quality and safety for the medical device industry. Andaman Medical has received the certification from BSI, one of the world’s leading standards and inspection organisations showing businesses how to improve performance, reduce risk and achieve sustainable growth.