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STORZ & BICKEL Announces Certification of Medical Vaporizers Under New EU Medical Device Regulations
STORZ & BICKEL Announces Certification of Medical Vaporizers Under New EU Medical Device Regu...
About this update from Canopy Growth Corporation
[{"type":"text","content":"\n \n \n \n STORZ & BICKEL Announces Certification of Medical Vaporizers Under New EU Medical Device Regulations\n \n \n /* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n.prntac{\nTEXT-ALIGN: CENTER\n}\n \n \n \n \n \n STORZ & BICKEL Announces Certification of Medical Vaporizers Under New EU Medical Device Regulations\n \n \n Canada NewsWire\n \n \n \n \n \n \n Certification reinforces STORZ & BICKEL's leadership position in medical device design, ensures continued availability of devices worldwide\n \n \n \n \n \n TUTTLINGEN,\n \n Germany\n \n \n ,\n \n \n July 20, 2023\n \n \n /CNW/ - STORZ & BICKEL GmbH (\"STORZ & BICKEL\"), the world-leading manufacturer of high-end and medically certified cannabis vaporizers and subsidiary of Canopy Growth Corporation (TSX: WEED) (Nasdaq: CGC), today announced the certification of its premium VOLCANO MEDIC 2 and the MIGHTY+ MEDIC, in accordance with the new EU Medical Device Regulations (\"MDR\").\n \n \n \n \n \n \n \n \n \n The new MDR regulations outline stricter quality requirements for medical devices manufactured in or imported to the EU than its predecessor, the MDD (Medical Devices Directive).\n \n \n The comprehensive certification process was conducted by TÜV SÜD, a renowned provider of certification, auditing, and testing services. The audit assessed several rigorous criteria of the (DIN) EN ISO 13485:2016 standard, requiring defined processes and documentation of the auditee's Quality Management System, the European Directive 93/42/EEC (MDD), and the European Medical Device Regulation (EU) 2017/745 – Annex IX Chapters I and III. Additionally, the audit encompassed MDSAP with country-specific requirements for\n \n Australia\n \n (TGA),\n \n Canada\n \n (HC), and\n \n the United States\n \n (FDA). STORZ & BICKEL passed the audit with outstanding results and zero findings.\n \n \n \"As the leading worldwide manufacturer of medically certified cannabis vaporizers, we understand the profound responsibility we have to our patients, and we take great pride in this achievement,\"...