Implementation of Medical Device Regulation for CE Marking Training Course

This course is now available online

 

This course will help you to implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market.

The course will also review the requirements of, and relationship between, the legal manufacturer, subcontractors/suppliers, notified bodies (e.g. auditing), and economic operators (importers, distributors, EU Representatives) according to their obligations by MDR.

How will I benefit?

This course will help you:

  • Implement the requirements of the European Medical Devices Regulation
  • Guide and support other people and partner organizations affected by MDR
  • Set up and update required documentation
  • Take the necessary steps for your organization to meet the MDR requirement
  • Maintain compliance to MDR and other/future documents related to Medical Device legislation
  • Systematically explore and implement more detailed and updated provisions (e.g. common specifications (CS), acts, standards)