EN 14126:2003 (TYPES 3-B, 4-B, 5-B, 6-B) MEDICAL DEVICES 93/42/EEC ISO 9001:2015(QMS) ISO 13485:2016 ISO 9001:2015 ISO 45001:2018 ISO 14001:2015 ISO 10002:2014 MEDICAL DEVICES DIRECTIVE 93/42/EC TECHNICAL REPORT ANR CERTIFICATE