Medical devices and IVD custom software development

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.