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Live Webinar
Managing Your Medical Device Reporting (MDR) Program for
Compliance Success
Date: Fri, July 10, 2015 Time: 10:00 AM PDT | 01:00 PM EDT Duration: 60 Minutes
Instructor:David Dills Location: Online Register Now
Overview:
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.
Areas covered in the session:
What form should I use to submit reports of individual adverse events and where do I obtain these
forms?
How will I know if I require more information about my medical device report?
Reporting device-related deaths and serious injuries and when these are not treated as a product
complaint
Understand the manufacturer's reporting requirements and expectations
Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
Learn what constitutes a MDR and how to facilitate this for compliance success
Develop, maintain, and implement written MDR procedures and achieve compliance
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: All levels of Management for all
departments and those who desire a
better understanding or a "refresh"
overview
QA/QC
Regulatory Affairs and Compliance
Engineering/Technical
Services/Operations
Consultants
About Speaker David Dills Regulatory Affairs and Compliance
Consultant, David Dills Regulatory Affairs &
Compliance Consultant currently
provides regulatory, compliance and
quality consultative services for
medical device and
pharmaceutical/combination
manufacturers, and also has
an ...more
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