Managing Your Medical Device Reporting (MDR)Program for Compliance Success by globalcompliancepane


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                                                                                      Live Webinar on

Managing Your Medical Device Reporting (MDR)Program for
Compliance Success

Date: Wednesday, March 13, 2013                                       Time: 10:00 AM PST | 01:00 PM EST

Course "Managing Your Medical Device Reporting
(MDR)Program for Compliance Success" has been                 Duration:      90 Minutes
pre-approved by RAPS as eligible for up to 1.5                Instructor:    David R. Dills
credits towards a participant's RAC recertification           Location:      Online
upon full completion.

                   David R. Dills
                   Industry Regulatory &                                  Register Now
                   Compliance Consultant,

David R. Dills, an independent Regulatory & Compliance Consultant with more than 22 years of hands-on
experience and a proven track record within the FDA regulated industry, has an extensive regulatory and
compliance background with Class I/II/III and IVD devices and managing and handling activities within the
global regulatory and compliance landscape.   ...more

Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive
significant medical device adverse events from manufacturers, importers and user facilities, so they
can be detected and corrected quickly. If you are a consumer or health professional you should use
the MEDWATCH program for reporting significant adverse events or product problems with medical

Although manufacturers and importers of medical devices have been required since 1984 to report
to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous reports have
shown there is widespread underreporting.

Areas covered in the session:

    l   What form should I use to submit reports of
        individual adverse events and where do I obtain
        these forms?
    l   How will I know if I require more information about
        my medical device report?
    l   Reporting device-related deaths and serious injuries
        and when these are not treated as a product
    l   Understand the manufacturer's reporting
        requirements and expectations
    l   Are there exemptions, variances, or alternative
        forms of adverse event reporting requirements?
    l   Learn what constitutes a MDR and how to facilitate
        this for compliance success
    l   Develop, maintain, and implement written MDR
        procedures and achieve compliance
    l   Learn why FDA is amending its MDR regulations to
        remove a requirement for baseline reports that the
        agency deems no longer necessary

Who Will Benefit:

    l   All levels of Management          Suggest a Topic
        for all departments and
        those who desire a better         More Webinars
        understanding or a
        "refresh" overview
    l   QA/QC
    l   Regulatory Affairs and
        Compliance                        Click here to
    l   Engineering/Technical           register for this
        Services/Operations                  webinar
    l   Consultants

It would be really nice if you can circulate this mail to all your deserving colleagues who can
immensely benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
Best regards,

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