target group
The seminar is aimed at quality management employees who are jointly responsible for the marketing of medical devices and who want to update their knowledge of the requirements for this.
content
The regulations for placing medical devices on the market are constantly evolving. The seminar gives an overview of the current status of the most important aspects when placing medical devices on the market. The event also offers the opportunity to discuss how to deal with the respective innovations together with an experienced speaker in the group.
topic overview
- Product Life Cycle – Development Process
- Technical documentation (Design History File, Device Master Record, Summary Technical Document)
- Classification of medical devices
- conformity assessment procedure
- Post Market Surveillance
- Clinical evaluation
- biocompatibility
- usability
previous knowledge
Prior knowledge of placing medical devices on the market is required.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
