Connecting Healthcare & Medical Device—Safely, Compliantly, and End-to End

"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 more easily.
wega also thankfully joined our ISO13485 surveillance audit in the absence of our QARA which was of great help to defend the proper setup of the QMS."

C. Morel, CEO, Axomove

“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

"Our workshop with the wega team provided a structured and very clear insight into standards, legal frameworks, and validation processes. The clear message that validation should always be based on process relevance and risk rather than a scattergun approach was particularly valuable. This practical approach strengthens biobanks' understanding of quality and compliance."

Dr. Alexandra Stege, Leitung der Zentralen Biobank Charité, 2025

"wega has been a trusted partner in both the implementation and ongoing support of our PK/PD database solution for over five years. Their approach has consistently demonstrated efficiency, pro-activity, and adaptability to our evolving needs. Notably, wega also led the successful validation of the system in alignment with GxP compliance requirements. We sincerely appreciate their professionalism, technical expertise, and the highly effective collaboration throughout our partnership."

N. Martinier, Clinical Data Manager, Product Development Team, MMV, 2025

"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

"The collaboration with wega Informatik was crucial for the successful implementation of our S/4HANA solution. Their in-depth expertise in the field of CSV (Computer System Validation) and their practice-oriented approach ensured that the necessary regulatory requirements in medical technology were met. wega Informatik demonstrated great skill in working across departments and delivered well thought-out solutions in a short space of time."

Thomas Hanselmann, Head IT Applications & Marius Heizmann,Group Manager Design Quality Engineering, Medartis, 2024

"wega supports us competently and reliably in bridging temporary resource bottlenecks in the area of software development. The wega employees integrate well and quickly into our teams, both professionally and personally. We have known wega as a fair and flexible partner for almost three years."

Michael H., Varian

"We had no in-house capabilities to work on a research project and wega provided us with a team of experts to drive our IT solutions (from requirements analysis to business case) in a challenging environment and with strict timelines. The wega team was very responsive and managed to deliver on time. We can highly recommend the team for such projects!"

J. M., Medium Pharma

"wega supported us with its distinctive expertise in the field of biobanking and the associated IT requirements in analyzing local needs and selecting an IT solution. The preparation of the comprehensive documents for the public tender could be implemented in a short time with wega's support and made it possible to select the best provider."

Public Hospital