Predictmedix Inc. (CSE:PMED, OTCQB:PMEDF) is gearing up to commercialize its Safe Entry Station in the EU and key global markets.
In a statement, the company said it has been granted Conformitè Europëenne (CE) Mark status and ISO13485 certification for its Safe Entry Station.
The CE mark declares the conformity of the Safe Entry Station with EU regulations and indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements. ISO13485 is the medical device industry's most widely used international standard for quality management.
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All Safe Entry Stations manufactured by the company's reseller, Paras Defence & Space Technologies Ltd., will now have the CE mark and ISO certification.
"The CE mark and ISO13485 certification are essential regulatory milestones for commercialization across Europe and the Middle East," said Rahul Kushwah, Chief Operating Officer at Predictmedix.
"They represent our first certifications for our unique product category and demonstrate that Predictmedix has the capability to manufacture and develop a product that meets performance, quality and safety requirements in the EU."
Kushwah added: "These exciting new global markets further expand upon our existing markets across North America, India and beyond. Our continued focus is on the aggressive, rapid achievement of profitability through the broad commercialization of our products alongside our tier-1 partners, helping to build sustainable value for our shareholders over the long-term.”
The company’s Safe Entry Stations - powered by a proprietary artificial intelligence (AI) - use multispectral cameras to analyze physiological data patterns and predict a variety of health issues including infectious diseases such as COVID-19, impairment by drugs or alcohol, or various mental illnesses.
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