CardioComm Solutions Secures Newest US and Canadian Medical Device 13485:2016 MDSAP Certification
MDSAP Certification to Expand Market Access for CardioComm's Medical Devices and Software
Toronto, Ontario--(Newsfile Corp. - October 21, 2019) - - CardioComm Solutions, Inc. (TSXV: EKG) ("CardioComm" or the "Company"), a global 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 certification 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.
About CardioComm Solutions
CardioComm Solutions' patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms for diagnosis and management of cardiac patients. Products are sold worldwide through a combination of an external distribution network and a North American-based sales team. CardioComm Solutions has earned the ISO 13485:2016 under MDSAP certification, is HIPAA compliant and holds clearances from the European Union (CE Mark), the USA (FDA) and Canada (Health Canada).
This release may contain certain forward-looking statements and forward-looking information with respect to the financial condition, results of operations and business of CardioComm Solutions and certain of the plans and objectives of CardioComm Solutions with respect to these items. Such statements and information reflect management's current beliefs and are based on information currently available to management. By their nature, forward-looking statements and forward-looking information involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements and forward-looking information.
In evaluating these statements, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company does not assume any obligation to update the forward-looking statements and forward-looking information contained in this release other than as required by applicable laws, including without limitation, Section 5.8(2) of National Instrument 51-102 (Continuous Disclosure Obligations).
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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