Qarad IVDR Conference 2022

Qarad IVDR Conference 2022

Actions and Detail Panel

€800 – €2,420

Date and time

Location

Hotel nhow Brussels Bloom

250 Rue Royale

1210 Bruxelles

Belgium

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Refund policy

No Refunds

In-depth training on IVD Regulation 2017/746

About this event

  • Regulatory state-of-play: what's new and what's coming?
  • Classification challenges and complex cases
  • The art of risk management and clinical benefit assessment
  • A practical approach on how to meet the various elements of clinical evidence under the IVDR, including scientific validity, state-of-the-art and performance evaluation plans and reports
  • How to set-up and document your clinical performance evaluation studies in compliance with the IVDR
  • How good design control can help you address regulatory requirements
  • Requirements imposed on IVD devices used in clinical trials
  • Impact of the IVDR on laboratories
  • Challenges and opportunities experienced when complying to the IVDR – an industry perspective
  • A Notified Body's point of view
  • How to build compliant pre- and post market documentation
  • Documentation required for Software under the IVDR
  • How to address PMS and PMPF requirements for both IVDR compliant and legacy devices
  • Electronic IFUs: what is required and what is the impact on your organisation?
  • EUDAMED: what can and what should you already do?
  • The art of assigning Basic-UDI-DIs and UDI-DIs
  • Best practice on managing the economic operators within your supply chain
  • The Impact of the IVDR on your Quality Management System
  • How to ensure continued access to the UK and Swiss market

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