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

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Faster

Bring your IVD medical device to the market faster.

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Less costs

Reduce the costs of your IVD software project.

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UX design

Improve the user adoption with great user experience design.

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Documentation

Have all documentation ready for regulatory authorities.

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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 medical and IVD 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).
Regulations and guidelines article

Ensure safe and reliable solutions

  • Top-tier technology stack for efficient performance and seamless operation.
  • Quality management, traceability and documentation of all software 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.
Regulations and guidelines article

“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

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?

We work in line with standards and regulations for IVD and medical devices

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Quality management systems

ISO 13485
ISO 9001

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Regulations implementation

IEC 62304
GxP requirements and implementation of FDA’s 21 CFR Part 11 features

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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 software development process and lifecycle

Software requirements specifications

Software Requirements Specification (SRS) contains detailed information and descriptions of how the software system will meet user requirements. In this phase of the software life cycle, we prepare the specifications in tight collaboration with the client, to establish a mutual understanding of all the details related to the wanted behavior of the software system and for risk management.

This technical documentation 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 the system must exhibit, such as durability, security, reliability, uptime, etc.

Depending on the project, this phase can include workshop/s, meetings, as well as usability tests, preparation of mockups, and prototypes. Detailed SRS document is an excellent basis for system design, development project costs, and the project timeline.

Software design specifications

The Software Design Specifications (SDS) contain detailed information on how the IVD 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 these 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 IVD 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 software 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 in vitro diagnostics domain knowledge can support you in software algorithm development, testing, and validation. Our medical devices and IVD software development team ensures the algorithm is correct, efficient, and meets the desired performance criteria.

We can create standalone software, or integrate algorithms 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 the software development team to ensure that the software is reliable, stable, and performs as expected. This step of the software development process is crucial for risk management.

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, performance evaluation, and feature enhancements, as well as ensuring compatibility with new operating systems and hardware.

Our goal is to keep your IVD software applications for medical devices up-to-date and running smoothly.

Software architecture consulting

We offer software architecture consulting services, 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 (standalone or embedded software) 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 for the target market. Our experts have hands-on experience in IVD medical and GxP-ready software development and will help you to analyze your existing software application(s), identify areas of non-compliance, and recommend 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, analyze raw data, 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 detailed information and descriptions of how the software system will meet user requirements. In this phase of the software life cycle, we prepare the specifications in tight collaboration with the client, to establish a mutual understanding of all the details related to the wanted behavior of the software system and for risk management.

This technical documentation 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 the system must exhibit, such as durability, security, reliability, uptime, etc.

Depending on the project, this phase can include workshop/s, meetings, as well as usability tests, preparation of mockups, and prototypes. Detailed SRS document is an excellent basis for system design, development project costs, and the project timeline.

Software design specifications

The Software Design Specifications (SDS) 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 these 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 in vitro diagnostics domain knowledge can support you in software algorithm development, testing, and validation. Our medical devices and IVD software development team ensures the algorithm is correct, efficient, and meets the desired performance criteria.

We can create standalone software, or integrate algorithms 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 the software development team to ensure that the software is reliable, stable, and performs as expected. This step of the software development process is crucial for risk management.

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, performance evaluation, and feature enhancements, as well as ensuring compatibility with new operating systems and hardware.

Our goal is to keep your IVD software applications for medical devices up-to-date and running smoothly.

Software architecture consulting

We offer software architecture consulting services, 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 (standalone or embedded software) 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 for the target market. Our experts have hands-on experience in IVD medical and GxP-ready software development and will help you to analyze your existing software application(s), identify areas of non-compliance, and recommend 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, analyze raw data, 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.

The right technologies for your medical device

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 medical device software.

How can we help you?

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