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In-Depth: Europe CE Marking Medical Device Approval and Compliance

 

Europe is the world's second-largest medical device market with 500+ million people and 20+ languages.  Fortunately there is only one approval process (CE Marking) for medical devices that grants you access to all 32 countries. In this detailed 21 minute, seven part slidecast, we will demystify the process of bringing your device to market in the EU, break it down into understandable steps and explain each one. Once you begin the series you may skip to the next section at any time using the playlist in the player window. 

  1. Overview of the CE Marking [4:40]
  2. Classifying your medical device [3:36]
  3. QMS requirements [2:19]
  4. Preparing a Technical File [4:17]
  5. Key players in the CE Marking Process [2:58]
  6. Final Steps [3:10]