Regulatory & Compliance Regulatory and Quality Systems at Extension Healthcare
One of Extension Healthcare’s technical strengths is the ability to connect to – and exchange data with – numerous varied clinical and information sources across the hospital enterprise. We recognize that these autonomous clinical information systems and devices may be designed to a variety of quality and regulatory standards. In order to meet these standards, Extension Healthcare has received a Class II U.S. Food & Drug Administration (FDA) clearance 510(k). This reflects our dedication to designing and developing quality products and the importance we place on our pivotal role in delivering clinical alarm and vital notifications.
For Extension Healthcare’s growing customer list this provides tangible assurance that our device has been designed, developed, verified, and validated to be safe and effective. Extension Healthcare also has implemented a Quality Management System (QMS) designed to comply with the FDA Quality System regulations 21 CFR §820 (cGMP/QSr) which provides further assurance of the consistency of our products.
Additionally, Extension Healthcare’s roadmap includes ambitious hospital alarm management and patient safety solutions that will leverage the discipline of a rigorous, world-class quality management system.
Health Canada Medical Device Clearance
Extension Healthcare has recieved medical device clearance from Health Canada to market and sell its Clinical Alert Notification solutions as a MDEL Class 1 medical device. The Medical Device Establishment License (MDEL) number assigned to this clearance is MDEL 6680. The official listing of this device on the Health Canada website is: http://webprod5.hc-sc.gc.ca/el-le/index-eng.jsp License #6680 (The above link shows Manufacture but the License describes in greater detail “Manufacture for Distribution”). The MDEL the Extension Healthcare received clearance for is for Manufacture, Distribution and Importing to Canada from the United States.