AI is rapidly conquering all areas of industry. However, particular caution is required in regulated industries. What requirements apply to the pharmaceutical and medical device sectors? The presentation provides an overview of the current regulatory background from the EU AI Act, EU MDR, and Annex 22. It critically examines whether AI can actually be used as an all-round expert in gaining expertise. How are the roles of customer and consultant changing?
Using a case study and insights into the introduction of AI at gempex, important milestones are highlighted and lessons learned are shared.