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.

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Diagnostics expertise

We understand laboratory workflows and data analysis.

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Regulatory readiness

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

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Interdisciplinary team

Combine software engineering with life science expertise.

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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
Regulations and guidelines article

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
Regulations and guidelines article

Your strategic partner in IVD software development

Watch the video

“The easy-to-use C.WASH software and its intuitive design gave us a competitive advantage over the competitors in the field of plate washers and liquid dispensers. Many of our customers stated that besides the high quality of the instrument their decision to purchase C.WASH has been significantly influenced by the software.”

Julia Steinert, C.WASH Product Owner, Cytena

“It was our pleasure to work with BioSistemika. We really liked working with them in a highly integrated product development process. The challenging project required a steep learning curve for us all and time to adjust. However, with BioSistemika’s team, we were able to find the best compromises to achieve a successful modus operandi and reach the defined goals. In addition, we appreciate their professionality, flexibility, adaptivity to changes of plans, and capability of being very helpful, even in the more difficult moments.”

Maria Ricci, Data Analyst and Development Engineer, Spindiag GmbH

“Biosistemika has proven to be a valued partner in the development of innovative, long term and challenging project. The Biosistemika’s team covered a critical role in the project providing great support during the major technical decisions as well as discussions and suggestions about the best software approaches throughout the project. Frequent meetings and quick discussions during the software development allowed a continuous alignment to the new user needs raised during the project updates.”

Stefano Ceschia, Research and Development Manager, Alifax

LifeTaq-Analytics GmbH has been collaborating with BioSistemika for more than two years working closely together on the project to construct and program an automated 3D cell cultivation robot. We were able to enhance the prototype of the robot by introducing BioSistemika’s software. We really appreciate the constructive work and the relaxing atmosphere during the project and look forward to even closer cooperation in the near future.

Thank you for your trust and support in all matters.

Manfred Taschner, CEO, LifeTaq Analytics GmbH

“Our team was facing challenges with resource allocation while working toward ambitious development goals – this made it difficult to execute on our vision for a modern, intuitive analysis tool for our customers. Partnering with BioSistemika allowed us to overcome these limitations. They helped us develop the analysis software just as we envisioned—complete with a modern feature layout and improved user experience.

What stood out most was how organized, professional, and transparent they were throughout the entire process. Their responsiveness and structured approach made collaboration smooth and efficient. I would highly recommend BioSistemika to any team looking for a trusted development partner, especially when in-house resources are stretched and quality delivery is essential.”

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

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.

The right technologies for your specific device

How can we help you?

Leave us a message, and our specialists for IVD and medical device software development will contact you shortly.