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Quality Control & Regulatory Affairs PHD Medical's Quality Management System (QMS) drives the effectiveness and continuous improvement of all our business systems, processes, procedures, work instructions, forms and records in order to meet the stringent requirements of international medical device regulations. The QMS elements support the design, development, manufacturing, testing and installation of medical devices for our Expert Systems and Telehealth product/services lines of business throughout their life cycle; using a "cradle to grave" approach from New Product Introduction to Post-Installation support. Products and services are realized using a robust risk management process in accordance with ISO 14971. Our goal is to exceed customer expectations by providing dedicated, value-added medical diagnostic support services; delivering defect-free medical device products as well as ensuring user safety. PHD Medical has been awarded certification to ISO-13485, ISO-9001, and European Medical Device Directive 93/42/EEC with zero non-conformances on the first attempt. In 2005, we have been granted approval by the Canadian Regulatory Agency, Health Canada Therapeutic Products Directorate, for PHD Medical's first medical device license in our Expert System product line roadmap. PHD Medical's Management team is committed to ensuring that customer, regulatory, quality and operational performance requirements are understood, planned, implemented and effective, at all levels of our organization." Medical Licenses PHD Medical has the following medical device licenses. Televisit Medical Device License Quality Certificates PHD Medical has the following Quality Certificates. NPOSES and Televisit ISO 13485 CMDCAS Televisit Solutions ISO 13485 CMDCAS Televisit Solutions European MDD Directive 93/42/EEC |
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