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Course Name

OL-MDM-CEMARK: Recorded Webinar - Overview of CE Marking for Medical Devices

Slides

IMPORTANT: This is a recorded webinar.
Note: This course is free for BSI Internal Employees
The recorded version includes both Audio and the Web Conferencing Video.

Description

BSI’s “Recorded Webinar - Overview of CE Marking” gives students a broad understanding of the requirements of the Medical Device Directive and the CE Marking approach. Participants learn the basic and initial steps an organization needs to take to sell their medical devices in the European market by gaining an overview of how the Directives are structured. Participants will also understand the different medical device classifications, how they impact the risk assessment process, and how they affect an organization’s approach to obtaining CE Marking. This webinar will be a great first step for an organization that wishes to bring their medical devices to the European market effectively the first time or requires a refresher on the entire CE Marking process.

Prerequisite

Students should have a basic understanding of medical device manufacturing before taking this course.

Topics Covered

  • Understand the Purpose and Concepts of European Directives
  • Gain an Overview of the Requirements for CE Marking
  • Understand the Rules for Classification
  • Review the Routes to Conformity
  • Understand How Risk Management Is Related to the Medical Device Directive
  • Summarize How to Get Medical Devices to Market in the EU

    • Who Should Attend

  • Quality managers in the medical device industry
  • Regulatory and quality staff responsible for preparing or hosting CE Marking audits
  • Organizations new to the EU market with medical devices
  • Those who need an understanding of the New European CE Marking approach for medical devices
  • Personnel performing design and risk analysis for medical devices under development
  • Companies preparing ‘own brand’ or ‘private labeling’ devices

    • Course Timing

    This recorded version takes about 2 hours to complete.

    System Requirements

    An internet connection with at least Microsoft Internet Explorer 5 or Netscape 5. Also, Corporate Firewalls may prevent the dowload of the MP3 Audio file which can cause the course to hang. Only your IT department can determine if MP3's are being blocked.

    Slides

    Softcopy slides are available after registration by clicking on the Course Attachment icon in the Action column for the course.

    Certificate of Completion

     NOTE: E-Learning courses are typically available immediately upon enrollment.

    E-Learning
    Course DurationCourse Fee 
    0 DaysUSD $75.00Please log in to enroll.