Pre-Conference Workshop: Artificial Intelligence Knocking on Your Door? The Upcoming Artificial Intelligence Regulation’s Technical Documentation Requirements and How to Integrate Them Into an MDR Submission
Description; Time is of the essence for manufacturers of AI enabled medical devices as the Artificial Intelligence (AI) Act approaches finalization. Entities will need to shoulder the responsibility of demonstrating conformance to the Medical Device Regulation (MDR) and the upcoming AI Regulation. This preconference session will empower participants to understand the additional technical documentation requirements of the upcoming AI Regulation and how to effectively combine them with an MDR technical documentation submission. Moderators of this session will present examples for analysis and also highlight areas that may warrant extra scrutiny from Notified Bodies based on the type of device.
The Preconference workshops are not included in the Main Conference registration. You can register for the workshop via the website: Visit the website!
Learning Objectives:
Upon completion, participant will be able to strengthen their understanding of the requirements of a technical file as detailed in the Medical Device Regulation 2017/745 and upcoming Artificial Intelligence Regulation.
Upon completion, participant will be able to identify the required elements for particular technical files/dossiers based on a number of example products.
Upon completion, participant will be able to identify the portions of an AI enabled medical device technical file that have a high chance of scrutiny from Notified Bodies and develop an effective method of presenting this information with sufficient depth and succinctness.
