IVD & medical 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.
Watch our webinar: How to implement 21 CFR Part 11 features into your software
Recently we hosted a webinar on the topic “How to implement 21 CFR Part 11 features into your software“.
Watch the webinar to discover:
✔ Expert advice on practical implementation
✔ Examples from the industry
✔ Answered questions from the audience
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).
Enhance your internal team with our domain knowledge
- Interdisciplinary team that combines lab work experience with software development expertise and UX design.
- Vast experience in laboratory work, understanding of laboratory processes and end-users needs.
- Close collaboration with your team for a constant insight into the progress of your project.
- Trusted cooperation with no hidden costs and with transparent and responsive communication.
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 requirements and implementation of FDA’s 21 CFR Part 11 features
Medical device regulations
EU IVD, US FDA, UK MDR 2002
Discover more about IVD medical device software 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
From our portfolio
Are you planning a new IVD software project?
Send us a message and speak with our experts.