Contract manufacturing operations for diagnostic products and components under Good Manufacturing Practice standards. Includes process validation, quality assurance, and full regulatory compliance documentation.
Manufactured by
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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Zhuhai Biori Biotechnology Co., Ltd. · China
GMP and GMP-grade manufacturing services for biological reagents and diagnostic components. Supports scalable production with ISO 13485 and ISO 9001 certified quality management systems.
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Full-scale cGMP and ISO 13485 compliant manufacturing services for in vitro diagnostic products. Supports formulation, fill, finish, and distribution from concept to commercial scale.
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Contract manufacturing and assembly services for medical devices and healthcare products. Facilities are certified by national regulatory authorities and operate under GMP standards.
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