Preparing for the Upcoming EU Medical Device Regulations 2016

Topics

• Timeline for transition to the new regulations
• Scope of the new regulations
• New requirements for manufacturers, distributors, reprocessors and independent bodies
• Emphasis on high-risk devices with greater transparency and traceability
• Q&A
• Additional clinical trial requirements

Who should Attend

Attendees from device distributors, manufacturers and testers responsible for:

• Quality Testing
• Production
• Distribution
• Quality Assurance
• Clinical Testing
• Packaging and Labeling
• Post-Marketing Surveillance
• Product Recall and Withdrawal
• Regulatory Staff
• Consumer/Patient Complaints and Adverse Event Reporting
• Audit Staff