IntelligynAI – Regulatory support setting up a QMS and technical files for MDR
| Reference number | |
| Coordinator | Intelligyn AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | May 2024 - January 2025 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Competence Enhancement in Small Businesses 2024 |
Important results from the project
The goal of this application is to complete a fully developed quality management system and technical documentation, prior to the MDR application. • Completed Clinical Evaluation Report. • Completed Risk Management (ISO 14971). • Completed Quality Management System (ISO 13485). • Declaration of conformity (MDR and AI ACT) – once documentation is complete. • Submission of files to Notified Body.
Expected long term effects
Intelligyn AI-programvaran qualifies as a medical device according to MDR class IIb. The goal for Intelligyn is to take the solution to market through the regulatory process ourselves. We are currently running the regulatory/clinical studies at Södersjukhuset which will be completed in Q4 2025. The aim of the project is to take Intelligyn the final step towards a fully developed quality management system and technical documentation that can be approved when reviewed by BSI within a year.
Approach and implementation
The work would involved preparing all documentation and processes for compliance with the Medical Device Regulation as well as the AI Act. • Workshops involving different team members. • Building processes based on how operations are run in the team with room for growth. • Preparing documentation that reflects work processes, technical specifications, and collected/generated evidence. • Training to educate personnel on regulations, processes, and the importance of working in the systems created.