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Sponsored by:
Complimentary Virtual Conference
July 17, 2019 | 11:00 a.m. - 3:15 pm EDT
EU MDR -
Requirements & Implementation
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The EU Medical Device Regulation (EU MDR) require more than a few new SOPs. A profound overhaul of the regulatory approach in one of the world’s largest medical device markets, the EU MDR demands new procedures, evidence development, documentation, relationships, reporting, data management, and a reevaluation of legacy portfolios. Senior management should be involved in strategic planning for changes that can significantly affect a company’s business.
This complimentary, four-hour virtual conference, conducted by leading experts on EU MDR requirements and implementation, provides concise insights into key aspects of the regulation to help companies understand and plan for the impending changes.
Learning Objectives:
During this event, you will learn about:
• EU MDR provisions and timeline
• Strategic considerations and priorities
• The business impact of compliance
• New clinical evidence requirements
• Changes in postmarket surveillance
• Requirements for economic operators
• Supply chain considerations
• Labeling, IFU, and UDI requirements
• Risk management provisions
• Eudamed database reporting requirements
• Remediation of legacy devices
Who Should Attend:
• Senior management
• RA/QA
• Clinical
• Postmarket
• Compliance
• Legal
• Supply Chain
• Global strategy
AGENDA
11:00 am – 11:05 am Welcome and Introduction
Maria Fontanazza – Editor-in-Chief, MedTech Intelligence.Com
11:05 am – 11:30 am Implementation Overview
Dr. Basssil Akra, Vice President, Strategic Business Development, Global Medical Health Services, TÜV SÜD
11:30 am – 12:00 pm Strategies for addressing the unknowns around what product changes can be made in the soft transition?
Keith Morel, Ph.D., VP Regulatory Compliance, QServe Group
12:00 pm – 12:30 pm Clinical Data Evaluation under MDR
Carolyn McCuan, Consultant, QServe Group US, Inc.
12:30 pm - 12:45 pm HealthLink Europe Technology Spotlight
Kay Bonavita, VP, Sales, HealthLink Europe & International
12:45 pm – 1:15 pm PMS
Carol Romero, Associate Manager, Quality Programs, Stryker Neuro
1:15 pm – 1:45 pm Automating the various plans-reports needed under MDR - Managing the content tsunami
Marc Miller, Division President,TransPerfect Medical Device Solutions
1:45 pm – 2:10 pm EU MDR, UDI, Labeling - Regulatory Requirements
Mark Cusworth, VP, Research & Development, PRISYM ID
2:10 pm - 2:35 pm Economic Operators
Nic Pugliano, Regulatory Affairs - Medical Products, W. L. Gore & Associates, Inc.
2:35 pm - 3:00 pm Eudamed
Richard Houlihan, CEO, Eudamed Ltd.
3:00 pm – 3:15 pm Questions and Answers
All Faculty
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