Lehrinhalte
[list]
[*]Introduction
[*]Quality management system according to ISO 13485
[*]Processes according to the quality management system
[*]Verification and Validation
[*]Requirements of the MDR
[*]Classification and placing medical products on the market
[*]Risk Management
[*]Clinical evaluation and investigation
[*]Post-market surveillance
[*]The system of notified bodies
[*]Audits
[/list]
Literature
[list]
[*]2017/745/EU Medical Device Regulation
[*]ISO 13485: 2016 Medical devices Quality management systems Requiremenst for Stand: 12.03.2020 Seite 2 regulatory purposes
[/list]
[list]
[*]Introduction
[*]Quality management system according to ISO 13485
[*]Processes according to the quality management system
[*]Verification and Validation
[*]Requirements of the MDR
[*]Classification and placing medical products on the market
[*]Risk Management
[*]Clinical evaluation and investigation
[*]Post-market surveillance
[*]The system of notified bodies
[*]Audits
[/list]
Literature
[list]
[*]2017/745/EU Medical Device Regulation
[*]ISO 13485: 2016 Medical devices Quality management systems Requiremenst for Stand: 12.03.2020 Seite 2 regulatory purposes
[/list]
- Lehrende: Olaf Kessel-Deynet
- Lehrende: Andreas Röse
Semester: Inverno 2021/22