A workshop designed to help participants understand what is required by IVDR in terms of software and how to approach IVD software development. The session combines theoretical background with real use cases, technical recommendations, and best practices gained from successfully delivered projects.
Manufactured by
BioSistemika
Slovenia
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.
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MedNet EC-REP GmbH
Germany · 2 relevant products
IMQ Certification (Shanghai) Co., Ltd.
China · 1 relevant product
BIOMEX GmbH
Germany · 1 relevant product
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3 of 18 closest product alternatives
MedNet EC-REP GmbH · Germany
Expert regulatory support for Class A through Class D IVD products including self-testing devices under IVDR 2017/746.
IMQ Certification (Shanghai) Co., Ltd. · China
IVDR Certification service for in vitro diagnostic devices, ensuring regulatory compliance with EU In Vitro Diagnostic Regulation requirements. Comprehensive conformity assessment and quality management system certification for IVD manufacturers and distributors.
BIOMEX GmbH · Germany
Contract research organization service specializing in in vitro diagnostic test validation. Services include ethics approvals, study design, sample provision, laboratory analysis, and regulatory compliance documentation for EU IVDR, TGA, and WHO standards.
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