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Medical Device Reporting

AAMI's Medical Device Reporting webinar now available on CD!

If your company continues to struggle with the decision making process of identifying when an adverse event should be reported, has trouble making MDR decisions due to difficulty in interpreting key terminology, or if your company is looking for industry and FDA guidance on the MDR process, this CD is definitely for you!

On October 5, AAMI presented The Importance of Effective Medical Device Reporting, a webinar event that drew 464 members of the medical device community. If you missed the event but would find the materials presented informative and useful, you're in luck! CDs of the program, accompanied by participant handouts, are now available for purchase. The two hour webinar CD gives you an opportunity to hear directly from industry and the FDA as well as listen to questions and answers given during the live broadcast.

SPEAKERS

  • Annette Hillring, President, Hillring & Associates, Inc.
  • Deborah Yoder, Nurse Consultant, US Food and Drug Administration, Center for Devices and Radiological Health, Reporting Systems Monitoring Branch
  • Victoria Schmid, Consumer Safety Officer, US Food and Drug Administration, Center for Devices and Radiological Health, Reporting Systems Monitoring Branch

PROGRAM-AT-A-GLANCE

  • Overview of MDR regulatory requirements - the basics of 21 CFR 803
  • Review of definitions of key terminology
  • Discussion on the difficulties manufacturers encounter in the decision making process and tips on how to avoid them
  • Suggestions on effective MDR activities
  • Review of current guidance documents available to provide industry assistance

TO PURCHASE

The cost is $345 for seminar non-registrants and $245 for seminar registrants. Additional shipping charges will be applied to orders placed for shipment outside the US, US territories, Canada or Mexico.

THREE WAYS TO ORDER

  1. Phone - 1-800-332-2264, ext. 217, to order with credit card.
  2. Fax - Select and download the form and fax to 703-525-1424.
  3. Mail - Select and download the form and mail with payment to:

    AAMI
    Customer Service Center
    1110 N. Glebe Rd., Suite 220
    Arlington, VA 22201-4795

QUESTIONS?

For questions about ordering the CD, please contact AAMI's Customer Service Call Center at 703-525-4890 ext. 217 or 800-332-2264 ext. 217. For questions about CD content, please contact Virginia Schoenauer at 703-525-4890 ext. 247.

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