Artificial intelligence applications in the medical device industry are rapidly developing.
Through a comprehensive understanding on current industry expectations, medical device companies who are interested to develop the next state of the art AI driven medical applications can confidently work out the responsibilities and guide their safe development of AI technology for use in healthcare settings.

Participants of this course will equip themselves with the latest regulations and guidelines to develop artificial intelligence powered health applications. These will enable them to kick start the initial planning phases of developing AI medical devices.

  • AI medical devices and its key difference with traditional medical device software
  • Current regulations (MDR and IVDR) on software medical devices and which of the two does your AI medical device fall under
  • Risk classifications based on MDR and IVDR, specifically for AI and should there be other factors outside of the regulations that ought to be considered as well
  • IMDRF’s risk categorisation framework for software as medical devices, are they suitable for AI devices?
  • International standards applicable for developing an AI medical device

Medical device companies who are interested to develop AI applications.

Participant experience
Participants who have basic understanding of the medical device industry

The mode of training shall mainly be lectures and discussion on the materials prepared.
There will be some case studies for hands-on learning of the materials.

Encey Yao

Encey Yao

Regulatory Manager at Qritive Pte. Ltd
Encey has been with Qritive since its early stages and has dedicated more than 3 years studying and navigating a new Medtech start up through the uncharted territories of AI regulations amidst global shifts in regulatory trends. With an interest to create more meaningful discussion and deliberate dialogues in the safe development and application of Artificial intelligence in healthcare, Encey strives to learn and interact with others who are pursuing this interest as well.

This online training consists of 1 module:

05 October 2022 from 9:00 am to 1:00 pm CEST

Some days before the online training you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 465,00* (until 16 September 2022)

Ordinary: € 595,00*

Freelance – Academy – Public Administration**: € 370,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Appreciate current regulations on medical device software
Risultato atteso
Understand the gap between traditional medical device software and AI powered solutions
Risultato atteso
Equip your AI development team with relevant industry standards and expectations

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

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