Marjo Johansson
Director of QA&RA
Aiforia
Finland
Marjo Johansson leads Quality Assurance and Regulatory Affairs at Aiforia Technologies. She possesses a deep background in Quality Assurance and Regulatory Affairs within the medical device and IVD industries, with a proven track record in both startups and global organizations like Philips and Elekta. Since 2016 Marjo has worked with regulatory requirements and QA topics of innovative software products. Aiforia’s mission is to transform pathology image analysis with AI, enabling better care for each patient.
Topics
Manufacturer’s voice - lessons learned from IVDR path for AI software certification
Developing Health Technology
Artificial flavors you cannot survive without
5.2.2026 15:20 - 16:00 | 205 - Mylab
While the path to IVDR certification has been time-consuming and demanding significant effort for all companies, AI-based software products brings an unique flavor. In this session, Marjo Johansson provides a look at the IVDR certification journey from the perspective of an AI software manufacturer. The main milestones, primary challenges, and lessons learned are explored, alongside a reflection on the 'one-year-after' situation.