In a revolutionary move, STORZ & BICKEL GmbH, a leader in the production of premium cannabis vaporizers, has received certification under the new EU Medical Device Regulation (MDR) for its premium devices VOLCANO MEDIC 2 and MIGHTY+ MEDIC. This accomplishment guarantees not only the continuous availability of these devices across the globe. It also indluences STORZ & BICKEL’s status as a leading innovator in the field of medical device development.
STORZ & BICKEL and innovative moves
The MDR represents a significant advancement in the sector. It is thanks to adjusting strict quality criteria for medical devices throughout the European Union. The accreditation of STORZ & BICKEL demonstrates a dedication to creating high-quality goods. Their products adhere to the strictest standards, as the new requirements demand better quality assurances than the previous Medical Device Directive (MDD).
The thorough certification procedure was carried out by TÜV SÜD. It is a renowned provider of certification, auditing, and testing services. It also involves assessing several requirements of the DIN EN ISO 13485:2016 standard. The assessment also includes checking for adherence to European Directive 93/42/EEC (MDD), European Medical Device Regulation (EU) 2017/745 – Annex IX Chapter I and III, and the required documentation for the quality management system. The MDSAP (Medical Device Single Audit Program) requirements for Australia (TGA), Canada (HC), and the United States (FDA) were also covered as part of the certification procedure. STORZ & BICKEL not only exceeded these strict evaluations, but they did so with excellent outcomes and no complaints.
Comments about the new STORZ & BICKEL products
The founder and managing director of STORZ & BICKEL, Jürgen Bickel, expressed great delight in this remarkable accomplishment and emphasised the firm’s dedication to offering the finest patient experience.
“As the world’s leading manufacturer of medically certified cannabis vaporizers, we are well aware of the immense responsibility we have towards our patients. We will continue to build on our strong foundation of leading device design and stringent quality assurance and control standards to ensure the availability of our top-notch medical vaporizers for patients worldwide.”
With the release of the VOLCANO MEDIC 2 and MIGHTY+ MEDIC, which will likely hit the market in August, STORZ & BICKEL is further demonstrating their commitment to providing EU-certified products of outstanding quality. The MDR accreditation demonstrates the organisation’s dedication to placing patients’ safety and well-being first.
How does STORZ & BICKEL address market demand?
The MDR certification for STORZ & BICKEL vaporizers comes at a time when the demand for medical cannabis products is rising and the cannabis sector is expanding quickly. Approach towards medical cannabis is also changing everywhere. Vaporizers are a common way for patients to consume cannabis for therapeutic purposes. The EU-certified products of STORZ & BICKEL not only demonstrate their commitment to quality and compliance. It also places them in the centre of the developing cannabis business.
The MDR-certified vaporizers VOLCANO MEDIC 2 and MIGHTY+ MEDIC have accurate dosing and dependable performance. Thus they made to specifically satisfy the demands of medical cannabis patients. These vaporizers offer a secure, effective, and practical solution. We know that more patients look for alternative methods of consumption for their medical requirements.