Singapore-based Andaman Medical has become the first regulatory affairs consultancy focused purely on medical devices and the ASEAN region to win ISO certification for medical devices.

Andaman reported this week that it has received ISO 13485:2016 certification after implementing a vigorous quality management system which governs the firm's consulting services.

“I am extremely proud of the dedication of our team in achieving ISO 13485:2016. It embodies our ethos and recognizes that Andaman Medical meets the highest standards of the medical device sector which we serve," said Mourad Kholti, CEO and founder of Andaman Medical. "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 recognized standard of quality and safety for the medical device industry. Andaman Medical received the ISO certification from BSI, one of the world’s leading standards and inspection organizations showing businesses how to improve performance, reduce risk and achieve sustainable growth.

Andaman Medical was founded in 2013 by Mourad Kholti. The company comprises seven offices throughout the six main markets of the ASEAN bloc: Singapore, Malaysia, Indonesia, Philippines, Vietnam, and Thailand. Our in-house regulatory affairs, quality assurance and logistics teams assist medical device manufacturers and distributors worldwide to register and import their products to Southeast Asia.