Your European partner for end-to-end Contract Development and Manufacturing (CDMO) in In Vitro Diagnostics
From concept to commercialization, as a pure-player IVD CDMO, we leverage extensive expertise to deliver high-performance and customized solutions to guide our partners through the entire IVD lifecycle
From concept to commercialization
We cover the entire IVD lifecycle — from early-stage feasibility and product development, to regulatory and compliance pathways, routine manufacturing, global logistics and supply chain solutions, long-term lifecycle and product management.
Our professional team blends deep technical know-how, regulatory expertise, and operational excellence to accelerate time-to-market, ensure compliance, and deliver products that perform when it matters most.
Full product lifecycle coverage
Regulatory excellence
Cost control & security of supply
EU/france-based manufacturing
Global reach
1,100 sqm fully operational
Simplified/minimal contracting
Customisable configuration and QC release testing
Broad technology portfolio
ISO 13485 Certified
Scalable operations
Who we are
At Helio Diagnostics, we make innovation operational. With 25 years of IVD expertise, we provide the infrastructure and know-how to overcome technical, regulatory, and manufacturing challenges — helping partners worldwide to accelerate time-to-market and deliver reliable, compliant solutions at scale with agility, technical depth, and regulatory expertise.
From concept to market, or tailored à la carte services.
Regulatory & compliance
Regulatory Compliance Ensured – IVDR transitions, 510(k), clinical trial assay approvals
Flexible QMS Support – integrate with client or Helio QMS, audits & documentation ready
Global Regulatory Expertise – international registrations, FDA pre-sub, IRB submissions
Product development & industrialization transfer
Feasibility & Development: Assay design, laboratory work, pilot production, and development studies.
Industrialization & Tech Transfer: Management of new product transfer to production, execution of scale-up trials, ...
Process verification and validation
Logistic & supply chain
Contract manufacturing in accordance with Good Manufacturing Practices (GMP) and applicable standards, fully compliant with ISO 13485 and FDA 21 CFR Part 820 requirements. Over 25 years of experience in working and interacting with Regulatory Agencies and Notified Bodies, supporting worldwide registrations of IVD products. Capability to operate under our own Quality Management System (QMS) or seamlessly adapt to our clients’ QMS.
Manufacturing
Production of complete kits, components, and reagents (qPCR, NGS, IHC, mAbs, …), including kit assembly, warehousing, cold chain management, and worldwide shipping.
Product life cycle management
Post-launch support, monitoring product performance, and ensuring continuous improvement throughout the product’s lifecycle.
Experience
With a team of dedicated professionals, our capabilities cover the entire IVD value chain — from R&D scientists and regulatory specialists to manufacturing technicians, quality managers, and logistics coordinators.
Our team combines flexibility, integration, and operational excellence and brings decades of combined expertise to help you navigate technical, regulatory, and operational challenges with agility and precision.
Broad Sector Coverage
We support projects across multiple diagnostic areas, applying the same integrated, flexible approach to every project:
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Oncology,
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Infectious diseasess
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and more...
Quality
At the heart of everything we do, we operate under ISO 13485 and cGMP-compliant frameworks, with robust systems for reproducibility, traceability, and regulatory compliance. Our teams ensure that every step – from pilot batches to large-scale manufacturing – meets the highest standards, enabling customers to trust Helio Diagnostics as a reliable extension of their own operations.
Experience
With a team of dedicated professionals, our capabilities cover the entire IVD value chain — from R&D scientists and regulatory specialists to manufacturing technicians, quality managers, and logistics coordinators.
Our team combines flexibility, integration, and operational excellence and brings decades of combined expertise to help you navigate technical, regulatory, and operational challenges with agility and precision.
Broad Sector Coverage
We support projects across multiple diagnostic areas, applying the same integrated, flexible approach to every project:
-
Oncology,
-
Infectious diseasess
-
and more...
“Veracyte has selected Helio Diagnostics to maintain continuity of supply for our Prosigna IVD nCounter test. Having worked with this team before, we are confident that Helio Diagnostics is a partner we can count on to serve our customers outside the US.”
– Marc Stapley, Veracyte’s CEO
"Helio Diagnostics provides reliable manufacturing and technical support for our Ipsogen RUO and IVD products – a partner we trust for long-term collaboration. Their team ensured seamless technology transfer and lifecycle management for our IVD-R product registration, with ongoing technical support we can always rely on."
– Thierry Bernard, QIAGEN’s CEO.
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" Veracyte has selected Helio Diagnostics to maintain continuity of supply for our Prosigna IVD nCounter test. Having worked with this team before, we are confident that Helio Diagnostics is a partner we can count on to serve our customers outside the US. "
– Marc Stapley, Veracyte’s CEO
" Helio Diagnostics provides reliable manufacturing and technical support for our Ipsogen RUO and IVD products – a partner we trust for long-term collaboration. Their team has ensured seamless technology transfer and lifecycle management for some of our IVD-R product registrations. With their ongoing technical support, customer focus, agility and flexibility, they are a partner of choice. "
– Thierry Bernard, QIAGEN’s CEO.
