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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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How do you distinguish among a product complaint, a satisfaction complaint and a customer inquiry?
Does the FDA differentiate an instrument repair from a complaint?

Learn with FDA and Experts on March 18-19
Expert industry faculty teach you how to implement and measure the effectiveness of a complaint handling system covering a diverse set of possible products and problems; How complaint files are managed across multiple domestic and international facilities; how complaints rise to the level of MDRs.
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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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Learn the basic elements of the UDI regulation including the UDI labeling, #UDI database elements, and the timeline for compliance.

#FDA #CDRH OSB informatics staff explain the structure of the Global UDI Database (GUDID) and the details of account set-up and maintenance
In this 90-minute webinar, AdvaMed will introduce participants to the basic elements of the UDI regulation including the UDI labeling, UDI database elements, and the timeline for compliance.UDI Labeling:Each Packaging levelKitsUDI Direct MarkingStandalone Device SoftwareUDI Database:FDA Global UDI Database (GUDID) GuidanceData ElementsExternal & Internal DataElectronic Data SubmissionThen, take a comprehensive dive with FDA CDRH OSB informatics s...
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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
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 w...
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AdvaMed - MTLI

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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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AdvaMed - MTLI

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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
1
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AdvaMed - MTLI

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Learn the basic elements of the UDI regulation including the UDI labeling, #UDI database elements, and the timeline for compliance.

#FDA #CDRH OSB informatics staff explain the structure of the Global UDI Database (GUDID) and the details of account set-up and maintenance
In this 90-minute webinar, AdvaMed will introduce participants to the basic elements of the UDI regulation including the UDI labeling, UDI database elements, and the timeline for compliance.UDI Labeling:Each Packaging levelKitsUDI Direct MarkingStandalone Device SoftwareUDI Database:FDA Global UDI Database (GUDID) GuidanceData ElementsExternal & Internal DataElectronic Data SubmissionThen, take a comprehensive dive with FDA CDRH OSB informatics s...
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On July 22, 2014, the RoHS II legislative Directive becomes mandatory for #medicaldevice   and monitoring and control equipment placed on the market in the European Union.

Industry experts will discuss topics that will enable to you learn about key aspects of #RoHS   such as exemptions in the Directive, process requirements for compliance – non-destructive and destructive testing , how to maintain and support ongoing #compliance   resource needs to support these activities, and procedures and paperwork needed for Declaration of Conformity.

For more information: http://www.advamedmtli.org/go.cfm?do=Wercs.Show&wid=218
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Medical Technology Workshops for regulatory, reimbursement, legal & compliance, and sales & marketing professionals.
Introduction

At its core, medical technology is about innovation. It's about companies with big ideas working to transform healthcare through earlier disease detection, less invasive procedures and more effective treatments.

As an industry faced with increasingly complex legal challenges, an ever-changing regulatory landscape, inconsistent reimbursement guidelines, as well as strict rules governing the sales, marketing and advertising of its products in the global economy, it's amazing that medical technology companies ever get to "the business" of "their business."

As the pace of innovation increases, so to does the complexity of the business, regulatory, legal and payment issues affecting the industry – and professionals must continually seek new skills, knowledge and perspectives that enable them not only to respond to change, but to anticipate it.

As the educational arm of AdvaMed, the world's leading medical technology industry trade association, MTLI programs are designed to teach professionals the skills necessary to manage such obstacles and focus on what they do best – advancing the frontiers of 21st century healthcare. Our courses are designed to assist professionals with strategic planning and execution – providing new information and practices for immediate implementation.

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(202) 783-8700