2nd Medical Devices: Regulatory and Compliance Summit is organized by Vonlanthen Group of Companies and will be held from Feb 20 - 21, 2020 at Meliá Vienna, Vienna, Wien, Austria.
Who Should Attend?
Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Principal Scientists and Engineers specializing in:
• Medical Devices
• Controls & Robotics
• In Vitro Diagnostics
• Device Design
• Medical Device Design
• Sterilization
• Product Quality
• Regulatory Affairs
• Research & Development
• Validation
• Combination Products
• CMC
• Design Controls
• Device Development & Manufacturing
• Medical Device Engineering
• Quality Assurance/Control
• Compliance
• Risk Management
• Supply Chain
Description:
This process can be complex and challenging, and the 2nd Medical Devices: Regulatory and Compliance Summit is here to help. This two-day event provides the appropriate platform for industry leaders and regulatory professionals to discuss the best practices for implementing MDR and IVDR in the EU.
Key Practical Learning Points of the Summit:
• Overview of new guidelines, regulations and registration requirements
• Notified body feedback on EU MDR implementation
• Clinical affairs: data, evidence, equivalence and performance studies
• Achieving a smooth market access
• UDI implementation: challenges and opportunities
• Risk management changes
• Engaging medical device manufacturers with cybersecurity requirements
• Practical insights from medical device manufacturers
• Updating technical documentation and labelling
• Classification of medical devices
• Post-marketing adverse event reporting
Additional details will be posted as soon as information is available.
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