Bring high quality laboratory software to the market faster

Work together with experts that understand laboratories inside out.


We develop software for

Instrument Manufacturers

Software and software integrations for laboratory instruments.

Software Providers

Standalone laboratory and medical software applications.


Easy-to-use solutions for data management and data analysis in laboratories.

“Scientific software should be intuitive, user-friendly,
and communicate the expertise of the great minds behind it.”


We are specialised in different fields


Life sciences software development

Icon digitalization

IVD & medical software development

Tablet with PlatR software

Build user friendly software that solves the most complex problems

  • Our team listens to your requirements.
  • They combine lab work experience with UX design and software development expertise.
  • Our application specialists worked in the lab so they understand the needs of end users.
Tablet with PlatR software
featured image

UX design that focuses on enchaced usability

  • Great UX on top of the uncompromising safety and effectiveness.
  • Intuitive UX design for improved user adoption.
  • UX as an important selling point and competitive advantage.
  • Integration of UX in the complete software development cycle for reduced time to market.

Bring your product to the market faster

  • We work closely with your team so that you have a constant insight into the progress of your project.
  • Our communication is transparent and responsive.
  • We use state-of-the-art collaboration and project management tools that enable us to deliver projects on-time.

Our key technology expertise

We have extensive experience in interfacing with hardware instruments, either simple serial, Bluetooth or USB devices, as well as complex instruments with their own SDKs/APIs.

Our mobile development team can develop native Android (Java/Kotlin) or cross-platform (Ionic/Cordova/Angular) mobile apps that communicate both with hardware, as well as with the Internet.

We are also deeply rooted in desktop application development for Windows operating systems (C#, .NET, .NET Core, WPF).

Lastly, our web development team is fluent in web technologies and web application development. We have developed complex SaaS cloud solutions (SciNote), hybrid web applications, and designed powerful web APIs (REST, gRPC, WebSockets). Our technologies of choice are C#, ASP.NET Core and Ruby on Rails for the backend, and Angular and TypeScript for the frontend. We have also worked extensively with Amazon AWS, Heroku and Microsoft Azure web services providers.


Software development following regulations and stardards

We know the specifics and requirements of ISO 13485, IEC 62304, 21 CFR Part 11 and GxP. Therefore we develop:

  • Software for Medical Devices
  • Software as a Medical Device (SaMD)
  • GxP software for laboratories

We follow strict QA processes throughout the software development life cycle and perform software validation according to ISO 13485/IEC 62304. We also deliver to you necessary software-related documentation.

Discover more about our custom software development for the regulated environment.

Molecular mouse software screenshot

Watch our webinar: How to implement 21 CFR Part 11 features into your software

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

The following experts are involved in every project

Creating great software requires more than just coding. Every project should have a competent team who is overseeing the progress.


Application specialists

Application specialists have years of experience working in research and industrial laboratories. They are PhDs with domain knowledge in biotechnology, biology, physics, molecular biology, biochemistry, and pharmacy. Because they understand how laboratories work, they are able to design software so that it meets customer and end-user needs. They work with our customers to prepare software requirements, software specifications, lead technical meetings and workshops, and make sure that the project stays on-time and on-budget.

Senior software developers
With their extensive industry experience, senior software developers ensure the quality of the delivered software. They oversee the technical aspects of the project, decide on technological trade-offs, coach junior developers, and perform code reviews.
Software developers
Software developers play a crucial role in every project. They write the software code, design user interface, and integrate various hardware and software systems to bring the final product to life.
Quality assurance specialist
A quality assurance specialist’s job is to identify bugs, defects, and other quality-related issues, along with its study, analysis, and correction. They make sure that the project quality standards are followed in order to deliver a product of superior quality that meets customers’ specifications and exceeds their expectations.
Key account manager
Key account managers at BioSistemika are people who join domain knowledge from life science with business skills. They are a lead point of contact for all key client matters, including contracting, managing communications between key clients and internal teams, anticipating client’s needs, and work within the company to ensure the project deadlines are met. Based on their in-depth understanding of the laboratory digitalization and laboratory instrument market, they can help our customers with advice on their strategic decisions.
UX designer

UX designers are responsible for delivering an intuitive user interface of the software. They understand product specifications, develop wireframes and prototypes around customer 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.


Complete development life-cycle

We listen to your requirements and help you in any stage of the software development life-cycle.

Developer coding


User Requirements

The project begins with the user requirements phase, where the client’s requirements for the software system are captured in a User Requirements Specification (URS) document. This phase normally includes technical meeting/s with the end-users or clients to mutually define the intended use of the system, including all the actions that the system should support.
Very often, a Technical Proposal document is prepared alongside the URS document. This document presents our technical proposal regarding high-level user flows, user interface elements, and high-level system architecture.
Besides collecting the requirements, the purpose of these two documents is to allow us to roughly estimate the scope & timeline of the project at this time-point.

Software Requirements

In the second step, the Software Requirements Specification (SRS) is prepared. This document contains very detailed information and descriptions of how the software system will meet user requirements. SRS still describes what the software system will do (in great detail), not how the system shall achieve that. 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.

During this phase, tight collaboration with the client is crucial to establish a mutual understanding of all the details related to the wanted behavior of the software system. Hence, this phase can include additional workshop/s, meetings, as well as usability tests, preparation of mockups, and prototypes.

When SRS document is detailed enough, and by both parties, BioSistemika can prepare a more precise estimation of the system design, development project costs, and the project timeline.

Software Design

The goal of the Software Design phase is to write down detailed information on how the software will achieve its intended use. This is achieved by specifying in detail the design of the software system. In some cases, SRS document can already have a sufficient level of details in which case not much of an additional description is necessary to refine the intended use of the software. However, in most cases, Software Design Specification (SDS) documents need to be prepared. 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). At BioSistemika, these documents are often written in form of Epics. SDS documents are used as the blueprint of how the software will be built during the development phase, and represent a mutual agreement between BioSistemika and the client that these documents form the contractual basis on the software to be developed.

This phase can include additional meetings, preparation of mockups as well as usability tests, and prototypes. Additional documents, such as Risk Assessment, Technical Decisions Document, and a detailed plan of how the development lifecycle will be executed can also be prepared/started at this stage if agreed upon.

Also, at this time-point, a more precise estimation of software development project costs & timeline is prepared.


During this phase, the software system is developed according to the agreed lifecycle, scope, deliverables, and timeline. The deliverables of the project are split into smaller tasks by developers. If applicable, the software is being developed in iterations (sometimes called sprints), and regular reporting and updates with the client are also provided.



    This is a dedicated phase of the process that ensures the software was developed in compliance with the agreed specifications document. Validation of the software is performed by QA personnel on the project. If agreed upon, test scenarios are prepared and executed. To ensure that the software meets the specifications, all the discrepancies from the specifications are fixed (so-called bug fixing). After the execution of tests and after all issues are fixed, test report documents are created.



    If necessary and agreed upon, the software system is given to its users, and the maintenance period starts; during this period, BioSistemika ensures the software is updated (security fixes, minor improvements, and new features), as well as possibly being released to the users, or hosted and operated by BioSistemika.

    Are you planning a new software project?

    Speak with our experts and move your project from a concept stage into realization.