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  • EU MDR Software/AI Medical Device CE Marking Workshop

EU MDR Software/AI Medical Device CE Marking Workshop

24 April 2019

Hempsons, 100 Wood Street, London EC2V 7AN

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SEHTA Members cost: £240 +VAT

SEHTA non-Member cost: £280 

Why attend

There has been an explosion of new digital health technologies such as mobile health apps and artificial intelligence and software medical devices.  To sell software and AI as a medical device in the UK and Europe it must have the CE mark. The EU Medical Device Regulation (MDR) is in its implementation phase and will be fully effective from May 2020.  All medical devices including new digital health technologies will need to comply with these new regulations.

This one-day event will provide an overview of:

Software/AI medical device CE Marking Process, Software Device Classification and Conformity Assessment, Technical File including & Quality Management & Post Market Surveillance & Vigilance and the opportunity to hear from your peers.

Outcomes

  • Gain an overview of the new EU Medical Device CE marking process for software
  • Understand the key areas of compliance required
  • Understand the technical documentation that should be in place for each device
  • Key pointers for next steps

Target Companies:

Medical Device companies and Pharma companies with combination products.

Target Market: 

C-suite, executives, product owners, medical officers, regulatory and clinical specialists within a company that need to understand the overall requirements of the new Medical Device Regulation for their medical devices to enable them to place a device on the market and to maintain access after May 2020. All company sizes will find it useful, but particularly helpful for smaller, resource constrained organisations

Click here to view the agenda.

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