TORONTO, ONTARIO – CardioComm Solutions, Inc. (TSX VENTURE: EKG) (“CardioComm” or the “Company”), a leading global medical provider of consumer heart monitoring and electrocardiogram (“ECG”) acquisition and management software solutions, has completed its ISO 13485:2016 (“ISO”) certification in compliance with the Medical Device Single Audit Program (“MDSAP”), a mandatory requiment under Health Canada and accepted as an equivalent quality management ceterification by the USA Food and Drug Administration (“FDA”).
CardioComm’s ISO MDSAP certification ensures continued compliance and larger market access for the sale of its hospital ECG Management System software, its direct to consumer HeartCheck
™ ECG devices and its newest GEMS™ Mobile and Universal Smartphone ECG management applications. Only after completion of the newly mandated and more complicated MDSAP ISO certification may any manufacturers of medical devices and medical software continue to import and sell their products to Canadian customers. Also, CardioComm’s class of ISO MDSAP certification confirms that the Company’s quality manufacturing systems and controls meet the FDA’s quality systems requirements. This equivalent certification means that the potential for the FDA to perform maintenance inspections has been removed, which alleviates an ever present pressure on any company with FDA approved medical devices.
The deadline for companies to complete the MDSAP ISO certification is January 1, 2020. It is believed that as many as one-third of the medical device companies that have previously sold into Canada may have decided not to comply with the MDSAP requirements (Quality Digest, 11/14/2018). A loss of ISO MDSAP certified medical device providers may prevent needed and previously available medical products from being accesed by health care providers and consumers in Canada (Globe and Mail 05/09/2018).
CardioComm has communicated to suppliers of devices that have been integrated with the Company’s GEMS™ WIN, GEMS™ Home and GEMS™ Mobile/Universal software applications that they now have the option for continued access to the Candian healthcare market. Under the Company’s new ISO MDSAP certification, CardioComm can now assume a licensing role for the continued import and sale of devices into Canada by device manufacturers that have not renewed their ISO medical device certification under the more stringent and costly MDSAP standard.
To learn more about CardioComm’s products and for further updates regarding HeartCheck™ ECG device integrations, please visit the Company’s websites at
www.cardiocommsolutions.com and www.theheartcheck.com.
