Electronic Medical Device Reporting Deadline is August 13th – Are You Ready?

Manufacturers and importers only have until August 13, 2015 to begin submitting all MDR reports electronically. Learn what you need to do to test and start submitting data by the FDA deadline. USDM Life Sciences and 123Compliance will also outline the different methods of submitting data and help you decide which option is best for your organization. We’ll also explain how moving your submission process to the Cloud provides a more efficient, effective, and time saving process.

  • Overview of the eMDR requirements
  • What you need to do now to start submitting data
  • eMDR submission options
  • Drag-and-drop regulatory reports in minutes
  • How to automate the submission process
  • Live Q & A session

About the Presenters:

David Blewitt, Vice President of Cloud Compliance, USDM Life Sciences
David is an accomplished Life Sciences Regulatory and IS Compliance Professional with extensive hands-on and leadership experience in the Pharmaceutical, Medical Device, Biotech and Blood Management Industries, specifically in the fields of; Computer Systems Validation, Risk Management, Issue Investigation – Root Cause Analysis and Remediation, Quality Assurance, Software Development Lifecycle, Lean IS Compliance Enhancement Initiatives, Business Analysis, Product Lifecycle Management and Systems/Process analysis with Compliance Roadmap development. He is an acknowledged expert on a wide range of regulatory predicate rules.

Bryan Coddington, Vice President of Cloud Technology, USDM Life Sciences
For almost a decade, Bryan has been a senior executive in the Cloud space with in-depth knowledge of sales, marketing, and service and support processes and best practices, helping companies maximize their investment in cloud-based CRM applications. Bryan is a hands-on delivery professional with 100+ projects on the Force.com platform including Sales Cloud, Service Cloud, Communities, Mobile, data migration, custom development, and integration.

Plarent Ymeri, CEO, 123Compliance
With more than 14 years of experience in the life science and healthcare industries, Plarent brings direct knowledge and expertise of software organization leadership, development, implementation and validation. Prior to founding 123Compliance, Plarent held IT leadership roles for some of the largest life science organizations in the world. He also founded two other life science and healthcare IT companies called Ylogics and Lentani Solutions.

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    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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