About us – Experts in Medical Software, Compliance & Digital QM Software Solutions
We are a cross-functional team of developers, engineers, and regulatory experts delivering smart, compliant solutions for the medical device industry. Combining technical depth with regulatory insight, we guide companies through digital transformation, product innovation, and regulatory compliance.
- Expertise in digital QMS tools and AI
- Hands-on experience with ISO 13485, FDA 21 CFR, and IVDR
- Proven track record in software validation, clinical affairs, and technical documentation
- Strong international collaboration across Europe
- Clear, structured, and audit-ready documentation
“Whether building custom tools or guiding complex submissions, we help manufacturers stay compliant, efficient, and ready for the future.”
Medical Device Regulation
Efficacy and feasibility is as important as compliance
Real-World Solution for Your Organization
We understand the regulatory environment. We have experience in implementing all standards related to medical software development, cybersecurity, and technical documentation, and we would be happy to demonstrate in practice how we can translate this expertise into real-world solutions while working on your medical device software product - as a developers a project managers.
Medical Device Software Development (SaMD/MDSW)
Medical Device Software Development
- Software Development
- Technical Documentation
- Medical Project Management
- Regulatory Compliance
Quality Management Digitalization
and Automation for ISO 13485
Future of Quality Management
At QMLogic, we empower organizations to revolutionize their Quality Management Systems (QMS) with cutting-edge automation tools. Our expertise spans Microsoft SharePoint, Power Platform, Confluence, Jira, and custom-built solutions tailored to specific needs.
