STORZ & BICKEL Announces Certification of Medical Vaporizers Under New EU Medical Device Regulations
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Certification reinforces STORZ & BICKEL's leadership position in medical device design, ensures continued availability of devices worldwide
TUTTLINGEN,
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
"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.
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,
Canopy Growth Corporation ("Canopy Growth") 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
Canopy Growth has also established a comprehensive ecosystem to realize the opportunities presented by the
Beyond its world-class products, Canopy Growth is leading the industry forward through a commitment to social equity, responsible use, and community reinvestment—pioneering a future where cannabis is understood and welcomed for its potential to help achieve greater well-being and life enhancement.
For more information visit www.canopygrowth.com.
This news release contains "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and "forward-looking information" within the meaning of applicable Canadian securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Canopy Growth or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release. Examples of such statements and uncertainties include statements with respect to the introduction of new products under MDR certification, including the timing, the anticipated outcome and quality of such new product launches, and expectations for other economic, business, and/or competitive factors.
Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, including negative operating cash flow; uncertainty of additional financing; use of proceeds; volatility in the price of Canopy Growth's common shares; inherent uncertainty associated with projections; expectations regarding future investment, growth and expansion of operations; regulatory and licensing risks; changes in general economic, business and political conditions, including changes in the financial and stock markets and the impacts of increased rates of inflation; legal and regulatory risks inherent in the cannabis industry, including the global regulatory landscape and enforcement related to cannabis; additional dilution; political risks and risks relating to regulatory change; risks relating to anti-money laundering laws; compliance with extensive government regulation and the interpretation of various laws regulations and policies; public opinion and perception of the cannabis industry; and such other risks contained in the public filings of Canopy Growth filed with Canadian securities regulators and available under Canopy Growth's profile on SEDAR at www.sedar.com and with the United States Securities and Exchange Commission through EDGAR at www.sec.gov/edgar, including under the heading "Risk Factors" in Canopy Growth's annual report on Form 10-K for the year ended March 31, 2023.
In respect of the forward-looking statements and information, Canopy Growth has provided such statements and information in reliance on certain assumptions that they believe are reasonable at this time. Although Canopy Growth believes that the assumptions and factors used in preparing the forward-looking information or forward-looking statements in this news release are reasonable, undue reliance should not be placed on such information and no assurance can be given that such events will occur in the disclosed time frames or at all. Should one or more of the foregoing risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated or expected. Although Canopy Growth has attempted to identify important risks, uncertainties and factors which could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. The forward-looking information and forward-looking statements included in this news release are made as of the date of this news release and neither STORZ & BICKEL nor Canopy Growth undertakes any obligation to publicly update such forward-looking information or forward-looking information to reflect new information, subsequent events or otherwise unless required by applicable securities laws.
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SOURCE Canopy Growth Corporation
FAQ
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