Qunuba Sciences successfully earns a certificate for conformance with ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP)

The company can now apply for Medical Device Licences on cannabis inhalational devices in rapidly growing medical cannabis markets, including Canada, Australia, New Zealand, Brazil, and the European Union.

Qunuba Sciences, a world leader in the development of cannabinoid delivery systems, is pleased to announce it has successfully earned a certificate for conformance with ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP).

MDSAP is a rigorous audit process covering the requirements of ISO 13485:2016 as well as participating regulatory jurisdictions, including Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW), and the United States (FDA).

“This achievement is a key milestone for Qunuba Sciences as we approach marketing of the world’s first medical-grade cannabinoid nebulization technology. Cannabis consumers in both the medical and wellness markets will have access to a safe alternative to burning or vaporizing cannabinoids without the unpredictable effect and slow-onset of edibles and oils,” said Vijay Sappani, co-founder and director of Qunuba Sciences.

The emergence of Qunuba’s technology directly addresses the need for trustworthy products in the inhalation of cannabis extracts. The precise-dosing device enables a more accessible intake experience due to the vaporless output of the underlying nebulization technology, meaning consumers can use the product in a wider range of settings than they are allowed with current vaping technology.

Qunuba Sciences’ nebulization platform consists of a proprietary extraction and formulation method for producing aqueous cannabinoid solutions, coupled with an optimized handheld medical-grade inhalational device. Nebulization provides the same rapid onset of effect as smoking or vaping, but without requiring heating of the material and the resulting generation of toxic compounds. The proprietary aqueous cannabinoid solutions put safety first, using only inactive ingredients that are Generally Regarded as Safe (GRAS) and are also used in FDA-approved inhalational medicines.

Qunuba’s multidisciplinary team of engineers and pharmacologists has successfully commercialized dozens of medical products approved by FDA, Health Canada, and other major regulators around the world. The team will continue to leverage this expertise to create innovative products that have a positive impact on for cannabis consumers.

About Qunuba Sciences 
Qunuba Sciences, founded in 2018, is a privately owned Canadian company focused on the research, development, and commercialization of safe and effective cannabinoid technologies. For more information, please visit qunuba.com.


Contact Name: Vijay Sappani         
Contact Title: President     
Contact Email: [email protected] 
Contact Phone: +1-416-716-1522

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