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Advancing reliable diagnostic performance at scale
Scaling diagnostics globally requires more than capacity.
Thermo Fisher's Diagnostic Services team integrates development, manufacturing, and regulatory systems to help deliver compliant, scalable performance across the lifecycle — to help reduce risk and strengthen execution in complex global markets.
Your infrastructure partner for global diagnostic scale.
Global expansion is increasing lifecycle complexity
Regionalization, evolving regulatory requirements, and platform consolidation are reshaping how diagnostics scale. Fragmentation can introduce duplication, misalignment, and operational risk.
Sustained performance often depends on enterprise alignment across development, manufacturing, and regulatory governance.
Thermo Fisher Scientific delivers ready-to-deploy and co-development solutions supported by a global manufacturing footprint and deep technical experience.
Coordinated execution across the diagnostic lifecycle
From research through commercialization, we support cross-functional execution designed to enable performance at global scale — enabled through five integrated capability domains:
Global manufacturing and operational continuity
Supporting multi-site production and global supply continuity.
- End-to-end manufacturing capabilities designed to support scale
- Global manufacturing optimization and capacity readiness
- Capacity readiness and structured tech transfer
- Dual sourcing and supply-risk mitigation
Operational stability. Consistent performance. Sustained scale.
Lifecyle execution and innovation
Integrated program governance across development, transfer, and commercialization.
- Assay development across diagnostic disciplines
- Instrument development from benchtop to total lab automation
- Ready-to-deploy and co-development solutions through commercialization
- Coordinated launch and support for clinical adoption
Support faster speed to market. Performance designed for scale
Regulatory and quality systems
Supporting global compliance readiness through aligned quality and regulatory systems.
- IVDR- and MDSAP-aligned quality systems
- Integrated change control and cross-regional impact assessment
- Supports audit readiness and regulatory continuity support
- Enterprise risk management. Stronger oversight
Reduced enterprise risk. Stronger oversight.
This coordinated model is applied across diverse diagnostic disciplines and supported by global manufacturing infrastructure and quality systems.
Broad experience across diagnostic modalities
Our capabilities span major diagnostic modalities, applying consistent manufacturing, quality, and supply chain systems across each platform.
Global manufacturing
Our global manufacturing network enables scalable, multi-modality production while preserving validation continuity and supporting regional supply.
Global manufacturing capabilities
- Multi-site global manufacturing network
- 450,000+ sq ft production footprint
- Flexible end-to-end diagnostic operations
- Automation and high-speed fill lines
- Cold and frozen storage environments
- Supplier management and secondary sourcing strategies
Comprehensive manufacturing capabilities designed to support scale
Formulation
- Liquid formulation:
500 – 40,000L tanks
400,000L capacity
- Chemistry and immunoassay bulk formulation
Custom filling
- Custom container filling
- Variable volume filling (1ml vials to 210L)
- High-speed fill lines
Fill, label and pack
- Standard and custom labels
- Kit packaging – hand packed or automated
- Warehousing
Lyophilization and flammables
- Lyophilizers with significant drying capacity
- 40–455L Capacity
- Flammable material Refrigerators and Freezers
Global footprint
Global quality and regulatory systems
Our global quality systems and regulatory framework support sustained compliance, governance, and market access across regions.
Global quality and regulatory capabilities
- EU IVDR and FDA IVD registration support
- Global registrations across 110+ markets
- ISO 13485:2016 and MDSAP certified quality systems
- Change management and remediation support
- DHR audit review and release processes
Fremont, CA, US
- ISO 13485:2016
- MDSAP Certification
- APHIS Certification
- FDA Registered
- DEA Registered
- IVDR Certified
- Manufacturer License
Middletown, VA, US
- ISO 13485:2016
- MDSAP Certification
- APHIS Certification
- FDA Registered
- DEA Registered
- IVDR Certified
- Manufacturer License
Suzhou, China
- ISO 13485:2016
- FDA Registered
Hennigsdorf, Germany
- ISO 13485:2016
- MDSAP Certification
- FDA Registered
- IVDR Certified
- Manufacturer License
Vantaa, Finland
- ISO 13485:2016
- MDSAP Certification
- FDA Registered
- IVDR Certified
- Manufacturer License
Nimés, France
- ISO 13485:2016
- MDSAP Certification
- FDA Registered
- IVDR Certified
- Manufacturer License
Integrated lifecycle services and technical capabilities
Services across development, manufacturing, and regulatory execution — enabling consolidation, secondary sourcing, and scalable diagnostic growth.
>500 - 40,000L tanks
>400,000L capacity
Custom container filling
Variable volume filling (1ml vials to 210L)
High-speed fill lines
Standard and custom labels
Kit packaging – hand packed or automated
Warehousing
End-to-end diagnostic development services and solutions to optimize your portfolio
Low to mid throughput lab automation assembly
Benchtop IA and CC analyzers assembly
Support to accelerate speed to market by expanding the pipeline, expediting product development and optimizing portfolio value
Discovery and development of biological materials (antibodies, antigens)
Recombinant and plasma
Proprietary assay designs
Instrument and lab automation design
Software capabilities
Custom, OEM, and application development and V&V service
Experience with open / closed immunochemistry platforms
Robust stage gate and design control process
Clinical evidence generation, study planning and execution
Compiling regulatory dossiers and filing with global authorities
HEOR strategy, evidence generation
Specialty IVD assay portfolios ready to deploy on customer platform
Third party controls, instrumentation and automation solutions
Diagnostic portfolio solutions
Expand and differentiate your diagnostic offerings with portfolio solutions spanning controls, biomarkers, instrumentation, and OEM components.
From ready-to-deploy products to co-development programs, we enable portfolio growth with the manufacturing scale and regulatory infrastructure required for global commercialization.
Portfolio capabilities
Portfolio Highlight
Quality controls
Whether you need kit controls, third-party quality controls, or proficiency testing, our comprehensive portfolio—paired with advanced QC management software—designed to help safeguard assay performance and support customers with confidence.
MAS Quality Controls
Consolidated, stability-proven controls designed to streamline routine clinical testing.
- Broad analyte consolidation
- Extended stability for select products
- Ready-to-use formats
- Coverage across core and specialty assays
AcroMetrix Standards and Quality Controls
Molecular controls and validation panels designed to enable assay integrity and traceability.
- Traceable materials
- Sample-mimicking matrices
- Multiplex QC for advanced testing
- Support for validation and ongoing monitoring
LabLink 360 Quality Assurance Software
Accelerate QC review with real-time actionable insights.
- Centralized QC dashboards
- Exception-based workflows
- Peer comparison and Sigma metrics
- Audit-ready documentation
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