Custom IVD software development
Develop secure software for in vitro diagnostic devices, built for regulatory compliance and audit-readiness. From instrument control and data analysis to result interpretation and laboratory system integration.
From innovative assays to market-ready IVD software
Whether you’re developing a new diagnostic instrument, commercializing an innovative assay, or transitioning from RUO to IVD, we help you build software that meets scientific, technical, and regulatory requirements.
Diagnostics expertise
We understand laboratory workflows and data analysis.

Regulatory readiness
Develop software in line with IEC 62304, ISO 13485, and ISO 14971 to support IVDR compliance.

Interdisciplinary team
Combine software engineering with life science expertise.
Audit-ready documentation
Receive documentation ready for regulatory submissions.
Bring innovative IVD software to the market faster
Modern diagnostic devices generate increasingly complex laboratory data. Software must reliably control instruments, process analytical , support result interpretation, and comply with evolving regulatory requirements.
We help IVD manufacturers , analytical algorithms, and data processing solutions that address these challenges while supporting efficient laboratory workflows, regulatory compliance and reliable diagnostic performance.
Compliant software development
- Aligned with ISO 13485, IEC 62304, and FDA 21 CFR Part 11
- Audit-ready software documentation
- Well-established QA processes
- Comprehensive software verification and testing
- Support for FDA regulatory submission pathways: 510(k), De Novo, and PMA
- Software for IVD and research-use-only (RUO) applications
Ensure safe and reliable solutions
- Software designed for reliable diagnostic performance
- Traceability throughout the software lifecycle
- Risk management from requirements through release
- Intuitive user experience for laboratory professionals
- Integration with diagnostic instruments, LIS/LIMS, and laboratory systems
A trusted software development partner
- 100+ software projects delivered
- Transparent project management and reliable delivery
- Life scientists and application specialists with practical laboratory experience
- Extensive experience in software-hardware integration and interoperability
Your strategic partner in IVD software development
We develop software in line with international IVD standards and regulations
IVDR (EU 2017/746)
European regulation for in vitro diagnostic medical devices
IEC 62304
Medical device software lifecycle processes
IEC 81001-5-1
Health software and health IT security
ISO 13485
Quality management system for medical devices
ISO 14971
Risk management for medical devices
FDA QMSR (21 CFR Part 820)
US quality management system regulation
IVDR (EU 2017/746)
European regulation for in vitro diagnostic medical devices
IEC 62304
Medical device software lifecycle processes
IEC 81001-5-1
Health software and health IT security
ISO 13485
Quality management system for medical devices
ISO 14971
Risk management for medical devices
FDA QMSR (21 CFR Part 820)
US quality management system regulation
Watch our webinars
Recently we hosted three webinars on the topic of IVD software development. Explore these on-demand webinars to delve into the following topics:
✔ How to implement 21 CFR Part 11 features into your software?
✔ How to enter IVD market with your laboratory device?
✔ How to approach IVD software development?
Guide to IVD software development
Download the article and learn more about:
✔ Standards and regulations and for IVD medical devices
✔ 7 steps of software development life cycle
✔ What you gain when outsourcing software development for IVD devices
Our software development process and lifecycle
Our latest project in IVD software development
Software built by experts who understand diagnostics
Developing successful IVD software requires more than software engineering. It demands an understanding of laboratory workflows, diagnostic assays, analytical methods, and modern approaches to data analysis.
Our interdisciplinary team combines software engineers, life scientists, and laboratory experts to bridge the gap between scientific requirements and robust software development. The result is software that not only meets regulatory expectations but also supports reliable diagnostic performance and intuitive laboratory workflows.
From our blog
How can we help you?
Leave us a message, and our specialists for IVD and medical device software development will contact you shortly.
















