CE Marking for Medical Devices Training

Industry experts from Intertek will provide practical information on the EU regulatory system and how to secure necessary certifications required for market entry. You’ll walk away knowing:

  • The differences between the regulatory systems for medical devices in the US, Canada, and the EU
  • How to classify your device, and your options for conformity assessment under the Medical Device Directive (MDD)
  • The MDD’s quality management system requirements, and how ISO 13485 and ISO 14971 can help you
  • The requirements your Technical File must meet, including the use of harmonized standards
  • The steps of the EC certification process, and the timeline you can expect for its completion
  • The most common findings in on-site audits and Technical File/Design Dossier reviews

Session Dates and Locations:  For session dates and locations please contact us at business.assurance@intertek.com.


Course Duration: 1 day

Course Fee: US and International Attendees: $695.00 USD per attendee; Canadian Attendess: $695.00 CAD per attendee (includes lunches and refreshment breaks)

Group Rate: For groups of 7 attendees or more please contact us at business.assurance@intertek.com for a discounted rate.

Deliverables: Each attendee will receive a certificate for 0.8 CEUs (continuing education units) upon successful completion of the course.

To register for this course, please complete the following form. By selecting submit, you agree to the Public Training Terms & Conditions