Posts Tagged ‘Medtech & Digital Health’
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 MoreThe EU AI Act – Its potential impact on the Pharma Industry
The EU AI Act is a regulation brought up by the EU in response to the boom in AI use through the world and across all industries, enabling the use of AI in a very easy and accessible manner to the General Public.
Read MoreReferenzen : Leitung der Zentralen Biobank Charité
“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,…
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 : MMV
“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…
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 MoreFlaky UI Automated Tests
A flaky test is an automated test that generates inconsistent results, without any change being made to the automated test script.
Read MoreReferenzen : Medartis
“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…
Read MoreBuilding Connections and Growth in a Network Organization: Introducing Our Roles Framework and the Mentor Role
Today we are pleased to present our role concept – the basis of our network organization, which promotes clarity, orientation and growth.
Read MoreWhy CI / CD Significantly Improves Your SaMD / MDSW Development Process
When developing standalone medical device software or software that is part of a hardware medical device, it is essential to have control over your code.
Read Morewega Breakfast – Agentic AI for Clinical Biomarkers in Research
22 May 2025
This talk outlines key GenAI achievements, introduces AI agents and their capabilities through published use cases, and highlights how Novartis (NVS) is leveraging these tools in clinical biomarker research.
Why 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…
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