CE Marking: Obtaining and Maintaining EU Compliance Under the Medical Device Directive

Instructor: Jeff Kasoff
Product ID: 701789
  • Duration: 60 Min
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.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2013

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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 Seminar:

  • 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

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

Follow us :
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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