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Regulation, Clinical and Software for Medical Devices


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November 5 - 7, 2024
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesota
November 5 - 7, 2024
The Royal Sonesta Minneapolis Downtown,
Minneapolis, Minnesota

EU MDR Implementation

Notified Body Feedback. Industry Case Studies. Post Market Surveillance. Clinical Requirements

highlights include:

The very latest on EU MDR Implementation

  • Best practice EU MDR implementation industry case studies from Alcon and BTG International
  • Assess the common implementation challenges faced by manufacturers in our interactive panel discussion
  • Hear Notified Body and Competent Authority feedback on implementation so far

Gain answers to the questions keeping you awake at night

  • Will your Notified Body have sufficient capacity and resource? When and how can you switch your Notified Body?
  • ISO13485:2016 – Quality Management Systems QMS) and the MDR: what’s new and how can you prepare?
  • What are the expectations for clinical evaluations and investigations under the MDR?

Best practice industry perspectives and Notified Body insight from:

  • Medtronic
  • BD
  • Alcon
  • GMED North America
  • Zimmer Biomet
  • Abbott