Über die Veranstaltung

Seminar Description:
Keywords:
- Regulatory Framework for Medical Devices (focus EU)
- Classification
- Conformance Assessment Procedure
- General Safety and Performance Requirements
- Technical Documentation
- (Harmonized) Standards
- Post market surveillance

Description:
This course provides an overview of the regulatory framework for medical devices, with a focus on the European Union, including classification rules, conformity assessment procedures, and general safety and performance requirements. Participants will gain insight into technical documentation, the role of (harmonized) standards, and key elements of post-market surveillance. The course equips learners with a foundational understanding of how to achieve and maintain regulatory compliance throughout the device lifecycle.

Target Group: Professionals and PhD candidates in medical technology and life sciences, Master’s students in Medical Engineering and related fields
Degree: Certificate of Participation
Link: https://www.medicalengineering.fau.de/education-mdr/