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AdvaMed - MTLI
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Medical Technology Workshops for regulatory, reimbursement, legal & compliance, and sales & marketing professionals.
Medical Technology Workshops for regulatory, reimbursement, legal & compliance, and sales & marketing professionals.

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Personalized medicine, biomarkers, and regulation of molecular diagnostics will be addressed at the Molecular Diagnostics Workshop.
March 5–6, 2014

Get more information: www.advamedmtli.org/go.cfm?do=Wercs.Show&wid=225

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Come learn more about Molecular Diagnostics and the Changing Landscape: Considerations and Implications - http://www.advamedmtli.org/go.cfm?do=Wercs.Show&wid=225

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Personalized medicine, biomarkers, and regulation of molecular diagnostics will be addressed at the Molecular Diagnostics Workshop.
March 5–6, 2014

Get more information: www.advamedmtli.org/go.cfm?do=Wercs.Show&wid=225

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Setting up a complaint system, auditing a complaint handling system, and health hazard evaluations will be taken on at the Medical Device Complaints, MDRs, and Reports Workshop. March 18–19, 2014 Get more information about this workshop: www.advamedmtli.org/go.cfm?do=Wercs.Show&wid=226

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What medical device reimbursement issues are impacting you all most today? How can AdvaMed be more involved?

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FDA Regulation 21 CFR Part 820 requires medical device manufacturers to establish and maintain device history records for each batch, lot, and unit they produce. Electronic Device History Records (eDHR) compile all records pertaining to the production of a finished medical device. eDHRs covers extensive documentation that includes dates of manufacture, quantity manufactured and when they were released, acceptance records to show that the device was produced according to device master records (DMR), identification labeling, and device identification and lot numbers..

Industry experts and AdvaMed members who are already benefiting from eDHRs will be sharing their experiences at this informative meeting to prepare you for increased FDA scrutiny in the future.

For more information: http://www.advamedmtli.org/go.cfm?do=Wercs.Show&wid=217
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