13.06 - 14.06.2019  STATUS
New Jersey, USA

RMD-USA2019 will follow on from the success of its European predecessors, (Prague 2016, Berlin 2017, Brussels 2018). In conjunction with EAAR (European Association of Authorized Representatives), an excellent panel of experienced professionals in this field will once again ensure a conference of noteworthy quality.

Topics to be covered, among others will be:

• Implementation of the New Regulations
• The Road to 2020: Overview of Regulatory Developments
• Major Regulatory Compliance Challenges for the Industry
• Challenges for National Competent Authorities
• New Legal Challenges to the Medical Device Industry
• Scope, Borderlines and Classification
• General Safety and Performance Requirements
• Practical Aspects of Clinical Evaluation: What needs to be updated now and how to plan for
Future Compliance under the MDR
• Impact of the MD/IVD-Regulations on Quality Management Systems
• View of a Notified Body on the MDR Implementation Steps
• Post-Market Surveillance
• Do you need to plan for PMCF and What are the Possibilities for Gathering PMCF Data?
• The Impact of Increased Transparency and Traceability Resulting from Eudamed and the
Introduction of UDI
• Vigilance
• What can we Expect from the MDR Authorized Representative?
• Special IVD Issues
• Software
• Conflicts Between Economic Operators

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