BioSistemika
Exhibitors
Information
Custom Software for Medical Diagnostics and IVD.
BioSistemika is a specialized software development partner for medical diagnostics and IVD companies, supporting the development and evolution of software for diagnostic instruments, platforms, and digital ecosystems. We combine deep life sciences expertise with advanced software engineering to deliver solutions that perform reliably in regulated laboratory environments.
Our key strength is an in-depth understanding of laboratory and diagnostics software development, including compliance with regulatory requirements such as FDA 21 CFR Part 11, ISO 13485, and IEC 62304. We help companies build software that is not only compliant, but also scalable, maintainable, and ready for certification and global markets.
We provide end-to-end software development, covering SRS and SDS, software architecture, development, testing, validation support, and long-term maintenance, along with complete documentation required for regulatory approval. Our consulting services include 21 CFR Part 11 implementation, UX/UI design for laboratory workflows, software architecture, and project management, ensuring efficient execution across the full product lifecycle.
Our references include global leaders in medical diagnostics, instrumentation, and life sciences, such as GatorBio, Malvern Panalytical, SGS, Teledyne Technologies, BICO, AliFax, and GeneFirst.
At WHX Labs Dubai, we are looking to connect with IVD and medical device companies planning new software development projects or upgrading existing RUO or IVD software with new functionality and compliance requirements, including 21 CFR Part 11. We are also open to partnerships with medical device and regulatory consultants seeking a reliable software development partner for their customers.
