CardioComm Solutions, Inc. has Received Approval on an Expanded ISO 13485:2016 Certification in Compliance with the Medical Device Single Audit Program
February 09, 2021 at 08:24 am EST
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CardioComm Solutions, Inc. has received approval on an expanded ISO 13485:2016 ("ISO") certification in compliance with the Medical Device Single Audit Program ("MDSAP") for Canada and the United States, to include pulse oximetry ("PO2"), blood pressure ("BP"), weight and temperature in addition to ECG monitoring hardware and software solutions. In addition to providing highly accurate consumer and outpatient ECG monitoring capabilities, the Company has been approached to develop solutions to ensure more traditional measurements are monitored with equal accuracy. To meet these requests, CardioComm's expanded ISO MDSAP certification scope will allow the Company to develop integrations with one or many devices that can each, or configured as a set of devices, monitor ECGs as well as any other bio signal of interest. Adding PO2, BP and temperature specifically will address 2021 new device integration and product development roadmap plans for the Company including those to be used for COVID-19 related health monitoring.
CardioComm Solutions, Inc. is a Canada-based company, which develops software, hardware and core laboratory reading services related to electrocardiogram (ECG) and ambulatory arrhythmia monitoring systems for medical and consumer markets globally. The Company's specialization is in the software engineering of computer based (ECG) management and reporting software. The software permits physician interpretations of ECGs and supports private and public payer fee-for-service billings. The Companyâs device connectivity and ECG management technologies are used in medical, consumer, clinical research and telemedicine solutions for the recording, transmission, viewing, analyzing, reporting and storage of electrocardiograms, for arrhythmia screening, diagnosis, and management of cardiac patients. Its Global ECG Management Solutions (GEMS) and GlobalCardio (Cloud based GEMS) products are licensed worldwide to hospitals, ECG commercial reading services and physicians.
CardioComm Solutions, Inc. has Received Approval on an Expanded ISO 13485: 2016 Certification in Compliance with the Medical Device Single Audit Program
CARDIOCOMM SOLUTIONS, INC. 
