Medical Devices: Regulatory and Compliance Summit
20-21

February 2019

Austria

Vienna

About

We would like to welcome you to Medical Devices: Regulatory and Compliance Summit on February 20th-21st, 2019 in Vienna, Austria. This event provides the appropriate platform for industry leaders and regulatory professionals to discuss the best practices for implementing MDR and IVDR in the EU. The Summit will shed light on classification, conformity assessment, and risk management in regulatory strategies to achieve compliance and ensure patients’ safety. Through case studies, interactive presentations, and discussions, attendees will learn...

We would like to welcome you to Medical Devices: Regulatory and Compliance Summit on February 20th-21st, 2019 in Vienna, Austria. This event provides the appropriate platform for industry leaders and regulatory professionals to discuss the best practices for implementing MDR and IVDR in the EU. The Summit will shed light on classification, conformity assessment, and risk management in regulatory strategies to achieve compliance and ensure patients’ safety. Through case studies, interactive presentations, and discussions, attendees will learn which regulatory strategy is applicable for their products, how to develop effective tactics, and achieve smooth market access. We are looking forward to your participation in this engaging Summit in Vienna in February!

more info
Who Should Attend

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Principal Scientists, and Engineers specialising in:

  • Medical Devices
  • Controls and 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
Key Practical Learning Points of the Summit

Overview of guidelines and regulations, registration requirements
Risk analysis and risk management for faster product realisation
Quality management systems
Clinical affairs: data, evidence, equivalence, and performance studies
Achieving a smooth market access
Sterilization process requirements
Updating technical documentation and labelling
Requirements for classification of medical devices
Higher patient safety at what price?
Post marketing adverse event reporting