Tue, Mar 31 | Webex

Software/AI Medical Device EU MDR CE Marking Workshop

SEHTA and Psephos Biomedica next workshop is on Software / AI Medical Device EU MDR CE Marking.
Registration is Closed

Time & Location

Mar 31, 2020, 2:00 PM GMT+1
Webex

About the Event

SEHTA and Psephos Biomedica next workshop is on Software / AI Medical Device EU MDR CE Marking.

There has been an explosion of software health technologies applying algorithms and artificial intelligence to  address  medical  needs,  furthermore  many  traditional  devices  are  adding  software  components  or becoming digital.

In order to make these medical technologies available in Europe they must be CE marked which is currently governed  by  the  Medical  Device  Directive and will  be replaced  in  May 2020 by  the  new EU Medical Device Regulations (2017/745 &746)

This one-day event will provide an overview of:

  • Software/AI medical device CE Marking Process
  • Software Device Classification and Conformity Assessment
  • Technical File Preparation including Usability, Risk Management & Clinical Evidence
  • Quality Management includingSoftware Design and Development
  • Post Market Surveillance & Vigilance
  • 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

Register now

Registration is Closed

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