STORZ & BICKEL GmbH, the world-leading manufacturer of high-end and medically certified cannabis vaporizers and subsidiary of Canopy Growth Corporation , announced the certification of its premium VOLCANO MEDIC 2 and the MIGHTY+ MEDIC, in accordance with the new EU Medical Device Regulations (“MDR”). 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).
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 Australia (TGA), Canada (HC), and the United States (FDA). STORZ & BICKEL passed the audit with outstanding results and zero findings.
“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,” said Jürgen Bickel, Founder and Managing Director of STORZ & BICKEL. “We continue to build on our strong foundation of leading device design and rigorous quality assurance and control standards to ensure availability of our premium medical vaporizers to patients worldwide.”
STORZ & BICKEL expects to introduce the VOLCANO MEDIC 2 and MIGHTY+ MEDIC to the market under MDR certification in August – once again setting a new industry standard and reaffirming the company’s commitment to exceptional quality.
For more information about STORZ & BICKEL, please visit www.storz-bickel.com.
About STORZ & BICKEL GmbH
STORZ & BICKEL GmbH is the global leader in the manufacture of high-end and medically certified cannabis vaporizers. With a commitment to quality, innovation, and compliance, the company has consistently delivered exceptional products that meet the highest industry standards. Based in Tuttlingen, Germany, STORZ & BICKEL continues to drive the advancement of vaporization technology, providing a safe and efficient means of consuming cannabis for medical purposes.
About Canopy Growth
Canopy Growth Corporation is a leading North American cannabis and consumer packaged goods company dedicated to unleashing the power of cannabis to improve lives. Through an unwavering commitment to its consumers, Canopy Growth delivers innovative products with a focus on premium and mainstream cannabis brands including Doja, 7ACRES, Tweed, and Deep Space. Canopy Growth’s CPG portfolio features sugar-free sports hydration brand BioSteel, targeted 24-hour skincare and wellness solutions from This Works, gourmet wellness products by Martha Stewart CBD, and category defining vaporizer technology made in Germany by Storz & Bickel.
