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Founded in 1994, Mednet’s Universal Medical division engineers and manufactures ambulatory cardiac monitors and supporting systems. While the division is vertically integrated with Mednet’s Heart-Care monitoring division, Universal Medical also markets its product line directly to physicians’ offices, hospitals and Independent Diagnostic Testing Facilities (IDTF’s). Based on direct feedback from the Heart-Care monitoring center staff, physicians, patients, and its other customers, Universal Medical can assess marketplace acceptance and user needs rapidly and accurately. Universal Medical takes this input and continually improves its product offerings. Universal Medical products are granted 510K premarket approval by the United States Food and Drug Administration (USFDA) before they are placed on the United States market. Universal Medical complies with both National and International medical device design and manufacturing standards. The Universal Medical quality system complies with the FDA Quality System Regulations (QSR) and is certified for ISO:13485, MDD 93/43/EEC (for sales in European Union), and Canadian MDR (for sales in Canada). Many of the Universal Medical products are CE marked for sale in the European Union and in other countries that recognize the CE mark. |
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