MedX Receives MDSAP Certification, The Highest Regulatory Standard in the Medical Device Manufacturing Industry
April 2, 2020 (Source) – MedX Health Corp. (“MedX”) (TSX-V: MDX) a leading medical device and software company focused on skin assessment in identifying suspicious moles and lesions by utilizing its SIAscopy optical scanning technology coupled with its SIAscopy on DermSecure™ telemedicine platform, is pleased to announce that it has achieved a recommendation for continued certification on successful completion of an audit under the Medical Device Single Audit Program (“MDSAP”).
MDSAP is a stringent audit process undertaken on medical device manufacturers’ quality management systems that is recognized by regulatory bodies for compliance of the regulatory requirements under ISO-13485:2016 and in addition, those in Canada, the United States and Australia.
“Achieving the MDSAP certification confirms our ongoing commitment to maintaining the highest quality assurance standards within the Medical Device Industry and provides compliance in all of the jurisdictions we are operating in, including Brazil. The entire MedX team is to be commended for the effort put in through this process,” commented Scott Spearn, President & CEO of MedX.
MedX, headquartered in Mississauga, Ontario, is a leading medical device and software company focused on skin assessment in identifying suspicious moles and lesions by utilizing its SIAscopy on DermSecure™ telemedicine platform, utilizing its SIAscopy technology. SIAscopy is also imbedded in its products SIAMETRICS™, SIMSYS™, and MoleMate™, which MedX manufactures in its ISO 13485 certified facility. SIMSYS™, and MoleMate™ includes a hand-held devices that use patented technology utilizing light and its remittance to view up to 2 mm beneath suspicious moles and lesions in a pain free, non-invasive manner, with its software then creating real-time images for physicians and dermatologists to evaluate all types of moles or lesions within seconds. These products are Health Canada, FDA, TGA and CE cleared for use in Canada, the US, Australia, New Zealand, the European Union and Turkey. MedX also designs, manufactures and distributes photobiomodulation therapeutic lasers to provide drug-free and non-invasive treatment of tissue damage and pain. www.medxhealth.com.
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This Media Release may contain forward-looking statements, which reflect the Company’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties.
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