Name
BioSistemika
Company Description
BioSistemika provides custom software development for IVD medical device manufacturers, pharma, and the life-science industry. Our greatest advantage is an in-depth understanding of laboratory software development that meets strict regulatory compliance requirements, including FDA's 21 CFR Part 11, GxP, ISO 13485 and EIC 62304.
We support our clients with software architecture consulting, algorithm development, software-related documentation, UX and UI design, and project management.
Product Categories (10)
Data Analysis & Management/Middleware, Interfacing/Interface Engines, Consulting Services, Contract Development, Custom Software, Design Services, Documentation, Custom Development, Software Services
Phone
+386 1 23 505 22
Address
Koprska 98
Ljubljana, 1000
Slovenia
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Advanced Software Architecture for Life Sciences
FDA and ISO software documentation in IVD and medical device industry