U.S. Medical Device Reporting Requirements
Medical Device Reports (MDRs) provide a mechanism for both medical device manufacturers and FDA to identify and monitor significant adverse events involving medical technology so that problems may be detected and corrected in a timely manner. With MDR records being a primary source of information for investigators during inspections, it is critical that organizations comply with the Medical Device Reporting regulation (21 CFR 803).
You won’t want to miss AAMI’s MDR webinar 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
- Is looking for industry guidance on the MDR process.
This webinar CD will give you an opportunity to hear directly from an industry expert on this important topic.
Over the course of ninety minutes, the program will cover: an overview of the requirements, definitions, Form 3500A, best practices, interactive scenarios, and FDA 483 warning letters.
| WHO SHOULD PURCHASE |
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| Instruction is targeted to quality assurance, quality system compliance and regulatory affairs professionals and personnel responsible for the submission of MDRs. | |
| QUESTIONS? | |
For questions about ordering the CD, please contact AAMI publications at 1-877-249-8226 or 240-646-7031. |
SPEAKER
- Lynette Makowski, Principal Consultant, Achieving RA/QA Compliance LLC, Evergreen, CO
WEBINAR CD
- Includes pdf of handout materials and webinar recording on CD
- $295 for webinar registrants
- $395 for non-registrant
- Please note: Domestic and international shipping rates apply
WAYS TO ORDER
1. Online – Purchase CD online.
2. Phone – 1-877-249-8226 or 240-646-7031 to order with a credit card.
3. Fax – Select and download the order form and fax to 240-396-5781.
4. Mail – Select and download the order form and mail with payment to:
USMDR Requirements CD – AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211