« Back to Subjects
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 |
Description
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.