The Quality Management System of Magle Chemoswed har been transformed from a traditional GMP system to a bilingual system also addressing the requirements of ISO 13485:2016 for Medical devices. After passing a successful onsite audit the ISO 13485 certification was granted on April 28, 2019 by the Notified Body CE Certiso, NB 2409.
The scope of the extended Quality Management system covers:
Design, development, manufacture and distribution of active pharmaceutical ingredients and polysaccharide based medical devices.
Magle Chemoswed continuously maintains our GMP certification.