Regulatory Affairs for AI Applications in Medical Devices

Online event on June, 22nd 2021

> Register now

In this online event we will focus on legal and regulatory aspects of AI applications in medical devices.

The use of Artificial Intelligence (AI) blurs the determination of classic software products because the training data alters the algorithm. AI applications could potentially be trained throughout the whole life cycle to continuously improve results. Hence, all stakeholders, e. g. regulators, industry and notified bodes, are facing new challenges: the potentially continuing modifications as well as being very much depended on carefully selected training data. Therefore, currently AI algorithms need to be implemented in a frozen state in medical devices to receive clearance for US or EU market access.

In our online event:

  • we will give you a brief overview on the current regulations
  • we will have a firsthand report from a start up currently developing a medical device using AI applications
  • and we will hear about the resulting legal consequences, especially matters of liability for manufacturers and operators


14:20Specific regulatory requirements for AI-based systems in medicine
Thorsten Prinz, VDE

* Regulatory challenges during the life-cycle
* Future regulatory trends for AI-based software
15:05Start up of AI-based software as a medical device – from the idea to the product
Juri Rohde, FUSE-AI

* Regulatory requirements and quality management system as an opportunity for the realization of AI-based medical devices
* Practice and theory: realization of AI as a medical device
* Between pandemic, company development and approval of AI-based software
* Challenge to the healthcare sector – Effectiveness and efficiency in our healthcare system
15:50Coffee break
16:05AI and Liability: Knowing and Managing Risks
Roland Wiring, CMS Hasche Sigle

* Who is liable if the AI application makes a wrong decision?
* Are AI applications more susceptible to litigation?
* Have there already been any judgments?
* Does the operator have to live in constant fear of legal consequences?
16:50Wrap up and closing comments
17:00End of event
> Register now


Stresemannallee 15
60596 Frankfurt am Main

Florian Schlögel
+49 69 6308 367

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