Qepler | summits & conferences | Medical Device Regulations Virtual Summit, 22-23 September 2021
Event Location:
Online Conference
22 - 23 September 2021

Conference Overview

Medical Device Regulations Summit 2020 is focusing on EU MDR and IVDR overview, appropriate challenges and strategies for their overcome; company, team and portfolio preparation to new regulations; technical documentation, labelling and clinical data adoption; risk management and quality management systems updates; compliance strategies; Unique Device Identification (UDI) system implementation; medical devices traceability and devices classification.

The featured talks on

  • EU MDR overview - main regulation changes, challenges you will meet during transition and strategies for their overcome.
  • Expansion of indications for a medical device -- what are all things that have to be considered to be successful.
  • Switching to the EU Medical Device Regulation. Preparing company to meet the Medical Device Regulation (MDR).
  • MDR transition – preparing your company and team. Adopting your technical documentation, labelling and clinical data to EU MDR. Process and conformity assessment.
  • Practical case study - Steps of the successful EU MDR implementation.
  • Adopting current medical devices portfolio to EU Medical Device Regulation.
  • Risk management transformation and new safety measures. In-depth clinical data assurance. EU MDR and MD risk management – implementation challenges overcome.
  • Medical devices reassessment for compliance and certification.
  • Revisiting your QA, risk management and post-market vigilance.
  • Updating quality management system to MDR. Key elements.
  • Unique Device Identification (UDI) system implementation for device tracking throughout the supply chain. Labelling. Post market requirements.
  • Medical Devices traceability requirements.
  • Medical devices reclassification based on new requirements. New classification rules.
  • MDR and IVDR. In vitro diagnostics classification.
  • Drug device combination products safety.
  • Biocompatibility and EU Medical Device Regulation.
  • Notified Bodies and Competent Authorities.
  • Authorized Representatives: EU Declaration of Conformity and technical documentation for non-EU manufacturers.

Meet our Speakers

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