TORONTO, ONTARIO – CardioComm Solutions, Inc. (TSX VENTURE: EKG) (“CardioComm” or the “Company”), a leading 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”), which is now mandatory under Health Canada requirements and recommended by the USA Food and Drug Administration (“FDA”).
CardioComm completing MDSAP for both Canada and the USA, solidifies the Company’s abilities to continue to produce and sell its Global ECG Management System (“GEMS™”) software globally. CardioComm is also a preferred importer, distributor and reseller of hospital and consumer ECG medical devices for organizations based outside of Canada such as the USA, China and Singapore.
Manufacturers of Class II, III, and IV medical devices, whether based in Canada or elsewhere, must report to the Canadian Medical Devices Bureau that they have either passed, or initiated the transition to an MDSAP audit by December 31, 2018. Failure to do so will result in manufacturers losing their medical device licences and the rights to have their products imported into or sold into Canada. As of November 14, 2018, only two-thirds of the medical device companies that sell into Canada have signed up for MDSAP (Quality Digest, 11/14/2018). This situation may cause a shortage of medical products available to health care providers and consumers in Canada (Globe and Mail, 05/09/2018).
With ISO under MDSAP, CardioComm has confirmed that it may contract with other medical devices makers that sell into Canada, but have decided not to renew their ISO medical device certification under the more stringent and costly MDSAP standard. Under this scenario, CardioComm can place non-MDSAP ISO-certified devices under the Company’s own MDSAP certification for a fee, gaining sole distribution rights for device sales in Canada and ensuring that established and emerging sales channels have continued access to needed medical devices. One such example involves the recent application for FDA 510(k) clearance of the HeartCheck™ CardiBeat by CardioComm on behalf of the original equipment manufacturer. While ISO under MDSAP is not required in the USA, CardioComm’s Canadian/USA MDSAP certification is accepted by the FDA and removes the need for routine FDA inspections. This certification will also help newly FDA-cleared products when applying for Health Canada medical device clearances.
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.