Referenzen : Specto Medical AG

“Our collaboration with wega Informatik enabled us to convert early stage academic documentation into a comprehensive, MDR compliant technical dossier. Their structured V&V plan and thorough testing supplied the Notified Body with the requisite evidence, facilitating CE marking for both PC and VR implementations. The team’s expertise in ISO, IEC and ISTQB standards supported our regulatory approvals. wega also delivered a comprehensive workshop on complex regulatory requirements for AI enabled medical devices. Their practical guidance on standards, risk management, and FDA aligned validation accelerated our internal readiness and informed our strategic decisions.”

Charly Leprince, QARA Manager SaMD at Specto Medical AG