Wie ist eine Weiterbildung in Qualitätsmanagement Medizintechnik aufgebaut?
How is continuing education, further training in quality management medical technology structured?
The continuing education, further training in Quality Management Medical Technology comprises two levels, Level I: Management Systems in Medical Technology; Level II: Regulatory Affairs. Level I comprises the modules: Quality management for medical devices according to ISO 13485 - basic knowledge; risk management for medical devices; design control; qualification and validation; deviations and improvements; documentation and traceability, supplier management and supplier audit as well as a practical assignment. Level II includes the modules: Regulatory Basics; Manufacturing Medical Devices; Requirements for Placing Medical Devices on the Market; Market Surveillance Medical Devices as well as a practical paper. Both levels lead to a diploma, which can be converted into a certificate after an examination.
