Glyconics Earns International Certification for Quality System
Glyconics has received an ISO 13485:2016 certification for its quality management system after an independent review by the British Standards Institution (BSI).
The international standard applies to quality management systems that provide medical devices and related services which consistently meet regulatory requirements.
The Glyconics certification covers the design and development of medical devices for the diagnosis and monitoring of chronic obstructive pulmonary disease (COPD) and the screening of diabetes mellitus.
The company was able to demonstrate during an inspection by BSI that its quality management system met medical device industry standards.