Medical Device Regulations Summit 2021

Conference Details

Date: 22 September 2021

Time: 07:30

Duration: 2 days

Location: Novotel Praha Wenceslas Square Hotel, Prague, Czech Republic

Cost: Please visit the website for more details.

Organiser: Qepler

Conference Website

Conference Description

Conference Overview

Medical Device Regulations Summit 2021 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.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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