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Quality Assurance and Device Certification

Semester: 3rd
Class hours/week: 2 lectures | 1 seminars
Credits (ECTS): 4
Form of assessment: Semester mark
Course director: Dr. habil Judit TURCSÁN
Course code: MSM610ANEG


The students must acquire quality assurance systems, a directives of quality guidelines, and steps of the standardization porcess of instruments. Basic definitions of quality assurance and quality guidelines; Legal background of quality assurance; Standrads-based control systems (MSZ EN ISO standards and latest versions); Formation of quality guideline systems; Tools and modes of quality development; Quality-control activities I.; Quality-control activities II.; Audits of quality guideline systems; Administrative background of quality assurance, legal measures; Standardization, management standards; EU certifications system, certification of products; Metrological knowledge, measuring, control; Calibration,validatition; Feautures and requisites of the quality assurance of medical instruments and tools.


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