Digital solutions for laboratories
We build custom laboratory software for laboratory instrument manufacturers, laboratories, and software providers. We are also a trusted partner for laboratory digitalization consulting.
We understand how laboratories work
IVD software development
Custom software development and documentation for medical devices in accordance with IVDR requirements. Build audit-ready software with intuitive UX and strong foundation for certification.
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Medical device software development
Custom software for medical devices, aligned with IEC 62304, ISO 14971, MDR, and FDA requirements using an ISO 13485-compliant development process. Built for safety, quality and performance.
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Pharma software development
Custom software development for pharmaceutical R&D, manufacturing, and regulated workflows. We connect systems, streamline data processes, and build compliant solutions that support digital transformation.
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Life sciences software development
From software requirements and risk assessment to coding, implementation, and validation. We cover specific modules or complete software development to help you bring your device to the market faster.
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Laboratory digitalization services
Connect laboratory systems, automate manual workflows, and improve data integrity. We help laboratories assess their current processes and implement practical digital solutions tailored to their operational needs.
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Laboratory software products
Our scientists lead the development of innovative products that streamline laboratory work, reduce manual work, and help teams achieve greated accuracy, consistency, and efficiency in everyday lab operations.
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Why work with BioSistemika?
DOMAIN KNOWLEDGE
Our scientists, laboratory experts, and software engineers form highly skilled interdisciplinary all in one teams that complement your expertise.
QUALITY
Our laboratory software solutions combine quality control, regulatory compliance, and intuitive UX design.
INNOVATION
We create innovative solutions for the most complex problems of biotech companies.
RELIABILITY
We help you bring your product to the market faster and accelerate your growth.
Trusted by innovators in life sciences, pharma and medical devices
From concept to compliance, we offer a full-service approach for scientific software
Software Development & Engineering
We design, build, and support user-friendly, efficient, and scalable software for life sciences, pharma, in-vitro diagnostics (IVD), and other industries.
Laboratory Digitalization
We support laboratories and organizations with expert guidance on LIMS, ELN, digitalization and change management strategy. We tailor our approach to the specific needs of every customer.
Compliance & Integrations
From device connectivity to 21 CFR Part 11 readiness, we ensure your software meets regulatory requirements and integrates smoothly into your existing ecosystem.
Workshops & Expert Training
Equip your team with the knowledge to meet compliance standards and navigate regulatory transitions like IVDR. Delivered by our in-house specialists and industry partners.
We transform laboratories with innovative digital solutions
Our latest projects
We are building a sustainable future
DATANA DNA Data Storage, one of BioSistemika’s internal projects, is addressing one of the key challenges of the digital era: data storage.
Our patented technology enables DNA Data Storage with significant advantages in terms of data density, stability, and sustainability.
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Let us work together
If you are looking to develop new laboratory software or digitalize your laboratory processes, we are here to help. Schedule a non-binding introductory meeting with us to see the synergies between us and the benefits for your company.
