Institute of Health Care Engineering with European Testing Center of Medical Devices (7180)

  • 8010

    Stremayrgasse 16 Graz

    Austria

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The Institute of Health Care Engineering focuses on the development, evaluation and validation of new point-of-care and sensor technologies as well as the analysis, modeling and simulation of biophysical and biomedical processes with the aim of establishing new technical approaches to support diagnosis and therapy. Methodological, technical, operational, organizational, economic and quality assuring aspects of intra- and extramural health care with particular emphasis on patient safety complements the research and teaching profile of the institute. With the European Testing and Certification Body for Medical Devices (PMG), Graz University of Technology is the only university in Europe with a body that is federally accredited to inspect and certify medical devices according to European norms and regulations. In addition, the PMG is also authorized to certify quality management systems of medical device manufacturers in compliance with ISO 9001 and ISO EN 13485. With their conformity assessment expertise as former Notified Body and the engineering expertise of the Technical Universtity, PMG thus offers manufacturers of medical devices a comprehensive range of engineering, testing and consulting services for the whole product life cycle and QS certification.

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