This CE marking training will discuss the recent changes to MDD (Medical Device Directive), how to identify non compliance areas, contents of the technical file and essential requirements document and how to select notified bodies for MD compliance.
Areas Covered in the Seminar:- Device classification distinctions, and what that means to you in terms of compliance burden.
- Technical File contents and organization.
- Review and selection of your notified body.
- How to show compliance with the Essential Requirements.
- Changes to MDD and their implications.
- What is expected for clinical data.
Who Will Benefit:This webinar will provide valuable assistance to all device manufacturers who wish to sell product in the European Community. The employees who will benefit include:
- Top management
- Regulatory management
- Quality Management
- Sales and Marketing Management
- Quality Engineers
- Other personnel involved in development and implementation of the QMS
