CE Marking – EU Compliance Under MDD

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.

Why You Should Attend:

Medical devices cannot be shipped to Europe unless they are in full compliance with the Medical Device Directive. The compliance burden is very different depending on the classification of the device.

This session will cover the Technical File and Essential Requirements document, in which design documentation must be maintained; unless you are intimately familiar with the requirements in advance, this could be a serious compliance issue. Also contained will be the recent changes to the MDD, noncompliance with which opens the possibility of cessation of certification. Also, unlike domestic (US) regulations, the MDD requires clinical data – methods for gathering this data will be reviewed. Notified body selection is a critical aspect of MD compliance – this webinar will share some tips and provide experience in this area.

Areas Covered in the Session :

  • 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

MD2236

Jeff Kasoff

Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.

Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.

membership
  Go PRIME   🛈 $ 240 SELECT
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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance