Registration
Info
The event is organized for between 4 and 12 participants. If the minimum number of participants is not reached one week before the start of the event, we reserve the right to cancel it. For organizational reasons, registration for our events usually closes 8 days before the event date. Thank you for your understanding.
Cancellations can only be made in text form and are possible up to 8 days before the event date. In this case, a cancellation fee of 25% of the ticket price will be charged and retained when the amount paid is refunded.
This means that 100% of the ticket price will be due in the event of a short-notice cancellation of 7 days or less.
Payment will be processed by eveeno on our behalf:
eveeno
Andreas Bothe
Ellenbogen 8
D-91056 Erlangen
Telefon: +49 157 57 00 00 59
E-Mail: info@eveeno.de
Umsatzsteuer-ID: DE262038183
Description
Artificial intelligence (AI)-based medical devices are subject to European Regulations 2017/745 (MDR) or 2017/746 (IVDR) and in Germany to the Medical Devices Implementation Act (MPDG). The EU Artificial Intelligence Act (AIA) results in even higher hurdles for market access. Furthermore, many AI-specific standards and guidelines are currently being published (e.g., by the IG-NB Interest Group of Notified Bodies for Medical Devices in Germany) and best practice methods for the development of AI models are constantly being updated.
The first challenge for manufacturers is to implement the development and evaluation of the AI model as processes in their quality management system in accordance with the respective requirements. Taking AI-specific features into account, other regulatory processes, such as those relating to the software life cycle and risk management as well as clinical evaluation and usability must also be adapted.
In our hands-on training, we first get to know a fictitious company and its AI-based medical device software. We look at the training and testing of a simple artificial neural network as an AI model, in so far as this is necessary for the regulatory treatment of the product. For this purpose, we use a real and publicly available AI model with a medical purpose as an example. We apply various regulatory templates (in English) step-by-step, which later can be transferred to your product.
Target group
The event is aimed at employees in medical engineering companies who deal with the regulatory compliance of AI-based medical devices. No (programming) technical knowledge is required for the AI model demonstrated here. It only serves to learn the procedure on a real product.
Agenda
08:45 | Welcome and introduction |
09:15 | Introduction to the regulatory requirements for AI-based medical devices
|
10:30 | Coffee break |
10:45 | We get to know our fictious manufacturer “AI Cancer GmbH” and his AI-based medical device software “Breast Cancer Prediction”
|
11:30 | Software life cycle and AI development process: procedure and documentation
|
12:45 | Lunch break |
13:45 | AI technical evaluation process: procedure and documentation
|
14:30 | Transparency of AI-based medical devices
|
14:45 | Coffee break |
15:00 | Adaptation of clinical evaluation and usability processes for AI-based medical devices
|
15:45 | Summary and discussion |
16:00 | End of the event |
Preliminary program. Subject to changes / adjustments
Event location
Haus am DomSalon
Domplatz 3
60311 Frankfurt am Main
Deutschland
Coordinates (lat, long):
50.11116, 8.684563
Show mapRoute planner