Medical devices and IVD custom software development
We meet strict regulatory requirements and provide you with audit-ready software with exceptional user experience.





















Move your project from a concept stage into realization

Faster
Bring your IVD medical device to the market faster.

Less costs
Reduce the costs of your IVD software project.

UX design
Improve the user adoption with great user experience design.

Documentation
Have all documentation ready for regulatory authorities.

Expertise
Work with our interdisciplinary team with a proven track record.
Bring high-quality laboratory software to the market faster
To ensure precise diagnostic or therapeutic information, IVD medical device software must be reliable and secure.
At our company, we have a deep understanding of the regulations and standards that apply to specific devices and follow them throughout every stage of our software development life cycle.
Expert software and documentation
- In line with 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).
Ensure safe and reliable solutions
- Top-tier technology stack for efficient performance and seamless operation.
- Traceability and documentation of all software development life cycle steps.
- Risk mitigation in all phases of IVD software development, starting from SRS phase.
- Great and intuitive UX for improved user adoption and competitive advantage.
Elevate your internal team with an experienced and trustworthy partner
- Over 100 projects launched in the last decade.
- Next-level project management and reliable delivery for minimal time-to-market.
- Application specialists with years of experience in diagnostic laboratories and an understanding of the essentials of working at the bench.
- Extensive experience in software-hardware integrations and standardization that enable interoperability.
Watch our webinars
Recently we hosted a webinar on the topic “EU IVDR: How to enter IVD market with your laboratory device“. Watch the webinar to:
✔ Discover the new regulatory requirements from IVDD to IVDR
✔ Understand the key aspects of software development and guidance on planning and preparing software documentation for IVDR compliance
✔ Learn how to approach the first steps towards the IVDR for IVD manufacturers
We organized 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
We work in line with standards and regulations for IVD and medical devices

Quality management system
ISO 13485

Regulations implementation
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
Our development process and lifecycle


- Software requirements specifications
- Software design specifications
- UX/UI Design
- Algorithm development
- Testing & QA
- Maintenance & support
- Software architecture consulting
- Software-related 21 CFR Part 11 readiness consulting
- Device connectivity consulting and integrations
- LIMS and ELN consulting services
Software requirements specifications
Software Requirements Specification (SRS) contains very detailed information and descriptions of how the software system will meet user requirements. We prepare it in tight collaboration with the client, to establish a mutual understanding of all the details related to the wanted behavior of the software system. The document normally includes functional requirements specification (related to features from a user point-of-view), as well as non-functional requirements specification (technical requirements), which are other technical qualities that the system must exhibit, such as durability, security, reliability, uptime, etc.
Depends of the project, this phase can include workshop/s, meetings, as well as usability tests, preparation of mockups, and prototypes. Detailed SRS document is excellent basis for system design, development project costs, and the project timeline.
Software design specifications
The Software design specifications contain detailed information on how the software will achieve its intended use. This is achieved by specifying in detail the design of the software system. The SDS documents cover both functional specifications (individual screens, features, functions, and user flows within the software), as well as non-functional specifications (user interface elements, technical architecture of the software system, and similar).
We usually write this documents in form of Epics and use them as the blueprint of how the software will be built. We can prepare additional documents for you, such as Risk Assessment and Technical Decisions Document.
UX/UI Design
We pay a lot of attention to UX design, since it can present a significant competitive advantage of device. Our team of designers are dedicated to deliver an intuitive user interface of the software.
They understand product specifications, develop wireframes and prototypes around your needs, find creative ways to solve UX problems (e.g. usability, findability) and communicate design ideas and prototypes to developers.
They join their UX expertise with UI knowledge to implement attractive designs that enable faster user adoption by the end-users.
Algorithm development
Our experienced algorithm developers with life sciences domain knowledge can support you in software algorithm development, testing and validation to ensure that the algorithm is correct, efficient, and meets the desired performance criteria. We can also integrate algorithm into a software application, thus enabling you to offer a complete solution to your customers.
Testing & QA
Our QA and testing teams work closely with development team to ensure that software is reliable, stable, and performs as expected. We perform manual and automated testing that covers functional testing, performance testing, security testing and others. The software QA and testing process also involves creating test cases, test plans, and test scripts to ensure comprehensive testing of the software.
Maintenance & support
Effective software maintenance is essential for ensuring that software applications continue to function correctly and meet the changing needs of users. BioSistemika‘s maintenance services include activities such as bug fixing, performance optimization, feature enhancements, as well as ensuring compatibility with new operating systems and hardware. Our goal is keeping your software applications up-to-date and running smoothly.
Software architecture consulting
We offer software architecture consulting service, where our senior software architects help you design software applications that are robust, scalable, and maintainable. We work closely with your internal teams to ensure that the architecture of the software application aligns with the organization’s business goals and technical requirements. At the same time, our architects, who have a deep understanding of the latest software development technologies and trends, can help you design software in a way that maximizes its reliability, security, and performance, while minimizing the risk of costly errors and maintenance issues.
Software-related 21 CFR Part 11 readiness consulting
Work with our experienced consultants to build a 21 CFR Part 11-ready software. Our experts have hands-on experience in IVD medial and GxP-ready software development and will help you to analyze your existing software application(s), identifying areas of non-compliance, and recommending best practices and technical solutions to ensure compliance with the regulation. Working tightly with the development team, we can develop and implement 21 CFR Part 11 features into software as well as provide necessary software-related documentation.
Device connectivity consulting and integrations
We help laboratories and device manufacturers define and implement connectivity strategy for their device porfolio. Our sofware development experts have hands-on experience in SILA2 standard, laboratory IoT projects and device integrations. Depending on your requirements and your business goals, they will work with you to find an optimal solution to your needs.
LIMS and ELN consulting services
Our experienced consultants with at-the-bench experience work closely with your laboratory personnel to understand their specific needs and recommend solutions to improve their workflows. LIMS consulting services focus on the selection, implementation, and integration of LIMS software systems to streamline laboratory operations. This includes assessing the laboratory’s existing data management processes, identifying areas for improvement, and recommending LIMS software solutions that can automate tasks and improve data accuracy and reliability.
ELN consulting services focus on selecting and implementing electronic laboratory notebook software solutions to help scientists and researchers organize, document, and manage their research data. This includes identifying the specific needs of the laboratory or research group, selecting the appropriate ELN software solution, and support during implementation, including change management training.
Software requirements specifications
Software Requirements Specification (SRS) contains very detailed information and descriptions of how the software system will meet user requirements. We prepare it in tight collaboration with the client, to establish a mutual understanding of all the details related to the wanted behavior of the software system. The document normally includes functional requirements specification (related to features from a user point-of-view), as well as non-functional requirements specification (technical requirements), which are other technical qualities that the system must exhibit, such as durability, security, reliability, uptime, etc.
Depends of the project, this phase can include workshop/s, meetings, as well as usability tests, preparation of mockups, and prototypes. Detailed SRS document is excelent basis for system design, development project costs, and the project timeline.
Software design specifications
The Software design specifications contain detailed information on how the software will achieve its intended use. This is achieved by specifying in detail the design of the software system. The SDS documents cover both functional specifications (individual screens, features, functions, and user flows within the software), as well as non-functional specifications (user interface elements, technical architecture of the software system, and similar). We usually write this documents in form of Epics and use them as the blueprint of how the software will be built. We can prepare additional documents for you, such as Risk Assessment and Technical Decisions Document.
UX/UI Design
We pay a lot of attention to UX design, since it can present a significant competitive advantage of device. Our team of designers are dedicated to deliver an intuitive user interface of the software. They understand product specifications, develop wireframes and prototypes around your needs, find creative ways to solve UX problems (e.g. usability, findability) and communicate design ideas and prototypes to developers. They join their UX expertise with UI knowledge to implement attractive designs that enable faster user adoption by the end-users.
Algorithm development
Our experienced algorithm developers with life sciences domain knowledge can support you in software algorithm development, testing and validation to ensure that the algorithm is correct, efficient, and meets the desired performance criteria. We can also integrate algorithm into a software application, thus enabling you to offer a complete solution to your customers.
Testing & QA
Our QA and testing teams work closely with development team to ensure that software is reliable, stable, and performs as expected. We perform manual and automated testing that covers functional testing, performance testing, security testing and others. The software QA and testing process also involves creating test cases, test plans, and test scripts to ensure comprehensive testing of the software.
Maintenance & support
Effective software maintenance is essential for ensuring that software applications continue to function correctly and meet the changing needs of users. BioSistemika‘s maintenance services include activities such as bug fixing, performance optimization, feature enhancements, as well as ensuring compatibility with new operating systems and hardware. Our goal is keeping your software applications up-to-date and running smoothly.
Software architecture consulting
We offer software architecture consulting service, where our senior software architects help you design software applications that are robust, scalable, and maintainable. We work closely with your internal teams to ensure that the architecture of the software application aligns with the organization’s business goals and technical requirements. At the same time, our architects, who have a deep understanding of the latest software development technologies and trends, can help you design software in a way that maximizes its reliability, security, and performance, while minimizing the risk of costly errors and maintenance issues.
Software-related 21 CFR Part 11 readiness consulting
Work with our experienced consultants to build a 21 CFR Part 11-ready software. Our expetrs have hands-on experience in IVD medial and GxP-ready software development and will help you to analyze your existing software application(s), identifying areas of non-compliance, and recommending best practices and technical solutions to ensure compliance with the regulation. Working tightly with the develpment team, we can develop and implement 21 CFR Part 11 features into software as well as provide necessary software-related documentation.
Device connectivity consulting and integrations
We help laboratories and device manufacturers define and implement connectivity strategy for their device porfolio. Our sofware development experts have hands-on experience in SILA2 standard, laboratory IoT projects and device integrations. Depending on your requirements and your business goals, they will work with you to find an optimal solution to your needs.
LIMS and ELN consulting services
Our experienced consultants with at-the-bench experience work closely with your laboratory personnel to understand their specific needs and recommend solutions to improve their workflows. LIMS consulting services focus on the selection, implementation, and integration of LIMS software systems to streamline laboratory operations. This includes assessing the laboratory’s existing data management processes, identifying areas for improvement, and recommending LIMS software solutions that can automate tasks and improve data accuracy and reliability.
ELN consulting services focus on selecting and implementing electronic laboratory notebook software solutions to help scientists and researchers organize, document, and manage their research data. This includes identifying the specific needs of the laboratory or research group, selecting the appropriate ELN software solution, and support during implementation, including change management training.
Our latest project
The right technologies for your specific device

Choosing the right tech stack for your project is essential for its success, especially in regulated medical device environments.
Our team of software developers and engineers is skilled in a broad range of programming languages, frameworks, libraries, databases, and other tools.
From stand-alone to embedded software, we choose the best tech stack to meet the needs and desired functionalities and features of your device.
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How can we help you?
Leave us a message, and our specialists for IVD and medical device software development will contact you shortly.