IVD medical device software development
Get audit-ready software with exceptional user experience.
Move your project from a concept stage into realization
Bring your IVD medical device to the market faster.
Reduce the costs of your IVD software project.
Improve user adoption with great user experience design.
Have all documentation ready for regulatory authorities.
Work with our interdisciplinary team with a proven track record.
Bring high-quality laboratory software to the market faster
Expert software and documentation
- ISO 13485, IEC 62304, GxP and FDA’s 21 CFR Part 11 standards and regulations.
- Audit-ready software-related documentation.
- Well-established QA processes and software validation.
- Extensive unit tests for software verification.
- Software for diagnostics and RUO (research use only).
UX design that focuses on enchaced usability
- Great UX on top of the uncompromising safety and effectiveness.
- Intuitive UX design for improved user adoption.
- UX as an important selling point and competitive advantage.
- Integration of UX in the complete software development cycle for reduced time to market.
Professional and reliable partner
- Over 90 products launched in the last decade.
- Experienced project managers with a proven track record.
- Application specialists with years of experience in the diagnostic laboratories, understanding of the essentials of working at the bench.
- Extensive experience in software-hardware integrations and standardization that enable interoperability.
Quality management system
IEC 62304, GxP and implement FDA’s 21 CFR Part 11 standard
Medical device regulations
EU IVD, US FDA, UK MDR 2002
Discover more about IVD medical device sofware development and regulations
Download the article and learn more about:
✔ Regulations and standards for IVD medical devices
✔ 7 steps of software development life cycle
✔ What you gain when outsourcing software development for IVD medical devices
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