Success story: Regulatory compliance for AI-supported medical products

Train the Trainer course on Thursday 8 August 2024 (10:00-11:00 CEST).

The first part will share useful and reusable information on AI in the healthcare sector.

The second part will present a German SME Success Story. AIcendence is a healthcare IT startup that provides a solution to automate lung disease diagnostics. Their analysis software operates as an AI co-pilot for automated cytological findings in clinical practice. Cyto-ML software guides laboratory personnel through the specific steps of sample preparation. The fully prepared slide is scanned and evaluated by the software using a machine learning (ML) model in the cloud, tailored to the slide scanner and type of finding. The software then provides results that can be exported in PDF, inclusive of current treatment guidelines, and makes them available to medical professionals.

The AIcendence Success Story will llustrate how EDIH.SH has helped AIcendence (healthcare SME) to successfully:

• Navigate the complex regulatory landscape
• Accelerate the development and approval process for their AI-based diagnostic tool, Cyto-ML
• Align product development with the EU's Medical Device Regulation (MDR) - market entry requirement.

Course agenda:

• Overview: AI in healthcare
• Success story: AIcendence
  • Customer needs
  • Customer solution
  • Results and impact with examples
  • Lessons learned
  • Key takeaways
• Questions & answers (participant discussion)

To enrol in and access this course and materials, please visit the eLearning Platform

Course provider: EDIH.SH (DE)