Posts Tagged ‘eQMS’
Referenzen : Axomove
“Our collaboration with wega enabled us to easily implement and validate a very nice, user-friendly and affordable electronic quality management system compliant to ISO13485 and accordingly close a corresponding opened non-conformity. wega also consulted us on how to best document our Software Development in accordance with IEC62304 by leveraging Jira and maintain our technical documentation…
Read MoreReferenzen : 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…
Read MoreRemediation of Medical Device Design History File
This white paper addresses the issue of DHF debt and how to resolve this debt through DHF remediation. It also addresses the reasons for DHF debt and best practices for effective remediation.
Read MoreReferenzen : QARA
“We worked with wega to implement and customize our ticketing system. They delivered a solution that perfectly met our needs. Their comprehensive training empowered our team to manage the system independently going forward. We look forward to continuing this partnership on future projects as our business grows. “ K. Müsch, QARA, 2025
Read MoreWhy You Should Prefer Modern Tools to Traditional Methods for Creating CSV Documents
This article looks at the benefits and challenges of introducing modern documentation tools for CSV and highlights their role in simplifying processes, reducing errors and improving traceability…
Read MoreChristophe
Managing Director
Board of Directors
CSV & QA