1. February 2018
Overview of the most important changes and tips on where to look if you are unsure about the classification.
News
- Regulatory Affairs
- From FDA Clearance to CE Marking: Bridging the Gap
- Regulatory documentation and support worldwide
- CE Marking: MDR & IVDR
- Technical Documentation Europe
- Regulatory Updates
- Responsible person according to Article 15 MDR
- Aktenfuchs
- Market access strategies
- qtec EuRep GmbH
- qtec CE-Med GmbH
- qtec TrendReport
- Quality Management
- Design Control
- Clinical Affairs
