Software/AI Medical Device EU MDR CE Marking Workshop
Time & Location
About the Event
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.
- 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