Things to know about the Medical Devices Act
The Medical Devices Act regulates the placing on the market, approval and control of medical devices throughout Germany. In this course, you will learn about the regulatory requirements for medical device advisors and safety officers and how to implement these requirements in your company. This knowledge will help you avoid violations of the Medical Devices Act, which is considered an administrative offence and is punishable by imprisonment. With this course you will be informed about all relevant legal requirements and you will receive valuable tips for the practical implementation in your daily business.
Contents of the course are:
- Definitions e.g. medical device, incident, corrective measure, recall
- Regulations: MDD, MPG §30 and §31, MPSV
- Tasks of medical device advisors and safety officers and their interaction
- Reporting system
The course is designed for employees of medical device manufacturers, especially for people who work in the field, as application advisors or safety officers.