New Medical Device Regulation is a conference dedicated to guidance and interpretation of the changes to the regulation in the field of new medical device.
New Medical Device Regulation covers topics such as:
- Introduction and background to the new regulation
- Key Preparation for successful implementation
- Increased vigilance and Post Market Surveillance – how to comply
- Notified Bodies: How the changes will impact NBs and manufacturer’s – including the new rules for IVD conformity assessment
- IVDs and companion diagnostics
- Clinical investigations – what is required
New Medical Device Regulation brings together attendees from:
- Clinical studies
- Regulatory affairs
- PMS
- Vigilance
- Technical support and business development
- Quality systems