Medical Devices for Beginners

• Preparatory e-learning course "Medical Devices Basics"
• Introduction to medical devices and regulatory fundamentals
• Classification and conformity assessment procedures of medical devices
• Clinical evaluation and clinical investigation
• Vigilance and market surveillance
• Advertising of medical devices
• Special topics: Combination products, software, and cyber security

Who should attend

• Research and Development
• Clinical Research Regulatory Affairs

This seminar provides a comprehensive introduction to European and german medical device legislation. You will gain well-founded knowledge of the legal framework and the key steps required for the development and market placement of medical devices. Our experienced speakers will share valuable practical advice to help you develop, evaluate, and monitor medical devices in a safe and compliant manner.

Two weeks before the live online seminar, all participants will receive access to the preparatory e-learning course "Medical Devices Basics" (Webcode: 24122541). The course consists of three modules covering medical device legislation, development and conformity assessment, as well as vigilance. This ensures you are well-prepared and able to address your individual questions during the seminar.

During the seminar, you will receive:

• A detailed introduction to the legal requirements and regulatory framework for medical devices
• Solid knowledge of classification and conformity assessment procedures for safe market entry
• In-depth understanding of clinical evaluation and requirements for clinical investigations
• Insights into vigilance, post-market surveillance, and the use of reporting systems
• Knowledge of legal advertising practices, software as a medical device, and cybersecurity requirements