IVD & medical software development

Get audit-ready software with exceptional user experience.

Move your project from a concept stage into realization

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

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).

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.

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.