Integration and support of quality management systems for ISO 13485 compliance and FDA 21 CFR Part 820 requirements. Includes audit preparation, documentation systems, and regulatory compliance frameworks.
Manufactured by
Helio Diagnostics
France
Helio Diagnostics is a European, independent CDMO dedicated to In Vitro Diagnostics (IVD), designed to support long-term partnerships with diagnostic and life sciences companies worldwide. With more than 25 years of industrial IVD expertise and an ISO 13485-certified manufacturing site in France, Helio Diagnostics provides a reliable European platform for companies seeking to scale, industrialize, or access the EU market. Helio Diagnostics supports partners end-to-end, from feasibility and assay development to IVDR support, scalable manufacturing, EU batch release, global logistics, and full lifecycle management. Non-competing and partner-first by design, Helio Diagnostics offers flexible engagement models, fast feasibility timelines, and transparent execution to help partners de-risk development, accelerate time to market, and build sustainable diagnostic businesses in Europe and beyond.
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