Diagnostic software

monitoringquality controldata exchange

In vitro diagnostics software development focuses on creating innovative and convenient solutions for lab or at-home health monitoring. Having hands-on experience delivering specialized IVD software, ScienceSoft develops IVD solutions following the requirements of FDA, IVDR, and ISO 13485. IVD Solutions We Develop For physicians Clinical decision support systems, IVD interpretation and reporting software For lab technicians IVD quality control software, IVD analytics software For patients Software for at-home diagnostic and monitoring devices ScienceSoft as an IVD Software Product Development Partner In healthcare IT since 2005. 150+ projects for the healthcare industry, including IVD software and Software as a Medical Device (SaMD) projects. 750+ specialists, including certified IT consultants, engineers, and project managers with 5–20 years of healthcare IT experience. Over 50% of our IT talents are senior-level specialists. Experience with HL7, FHIR, XDS/XDS-I, and other healthcare data exchange standards. Regulatory consultants to ensure compliance with FDA, IVDR, HIPAA, GDPR, GCC regulations (MOHAP requirements, ADHICS, PDPL), and Australian Privacy Principles. Software documentation according to ISO 13485, ISO/IEC 82304-1, IEC 62304, GxP, 21 CFR Part 820. ISO 9001, ISO 27001, and ISO 27701 certifications. What makes ScienceSoft different Driving success in healthcare IT projects no matter what ScienceSoft develops healthcare IT solutions that reduce care delivery costs and improve outcomes, no matter the challenges posed by diverse expectations of medical staff, shifting priorities, and resistance to change.