Certificates

ISO 9001:2015 – Quality Management System (Medical)

ISO 13485:2016 – Medical Device Management System

ISO 45001:2018 – Occupational Health and Safety Management System (Medical)

ISO 10002:2018 – Customer Satisfication Management System (Medical)

ISO 14001:2015 – Environmental Management System (Medical)

CE – EC declaration of conformity (Disposable masks, gowns, overalls)

FDA – U.S. Food and Drug Administration

Sterilization and Disinfection Certificate

GMP – Good Manufacturing Practice