Sagentia receives confirmation of registration to ISO 13485:2016

Sagentia, a Science Group company, announces that it is now registered to ISO 13485:2016, receiving confirmation of the transition nearly a year ahead of the February 2019 deadline.

This new International Standard specifies requirements for a quality management system to be used by organisations involved in one or more stages of the life-cycle of a medical device. Sagentia delivers innovation, product development and applied science consulting services to clients in the medical sector helping them design and deliver breakthrough medical devices.

“This is a very important achievement for Sagentia,” states Jo Morgan, Group Quality and H&S Manager at Science Group. “Developing medical devices is a highly specialised discipline. Meeting the requirements of this new Standard so far ahead of the deadline demonstrates our continued commitment to the medical device development and innovation work that we undertake with our clients.”

Sagentia has been 13485 accredited since 26 November 2007.