Quality Management in Medical Engineering

Course contents
  • - Basic principles of the regulatory environment of medical engineering
    - Overview of the statutory provisions and working methods within a regulatory environment; EU directives and other international laws e.g. passed by the U.S. Food and Drug Administration; legal challenges of the placing on the market of medical devices; relevant standards in medical engineering (ISO9001, ISO13485, technical standards)
    - Basic principles of quality management
    - Philosophies of quality management; process-oriented approaches to quality management systems pursuant to ISO13485; processes of quality management and their interactions;
    - Special applications in quality management
    - Detailed description of essential processes and methods of quality management in consultation with other lecturers (process validation, statistical methods, CAPA, FMEA, risk management pursuant to ISO14971, quality audit etc.); design control and the development of medical devices in accordance with legal requirements
    - Case studies of process validation and operations qualification
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