Experts in Rare Disorder Assay Validation and Service Implementation
Clinical Validation | Analytical Validation | ISO 15189 | UKAS | IVDR | LDTs
Our services
Assay Validation for Manufactuers
Design and deliver analytical and clinical validation studies with robust reporting.
We build the validation strategy around its intended clinical use, complexity and patient risk.
Specialist Testing implementation
Specialist and technically complex laboratory investigations, including
ADAMTS13, Platelet function, Other laboratory-developed and assays
Multi-Site Harmonisation
Support consistent implementation across laboratory networks through standardised protocols, site verification and cross-site performance assessment
Products
Material made to support diagnostics including IQC, calibrators and detection capture antibodies.
Quality and accreditation
UKAS/ISO 15189 support, documentation, audits and compliance readiness
Who ISOCHECKS helps
CLINICAL LABORATORIES
- Reduce implementation risk
- Access specialist expertise without the need to build every capability internally.
- Strengthen UKAS evidence
- Develop clear, comprehensive and traceable validation documentation.
- Build staff capability
- Training, competency support and knowledge transfer to your laboratory team.
DIAGNOSTIC ASSAY MANUFACTURERS
- Understand the clinical laboratory environment
- Gain practical insight into how your assay will perform within real-world diagnostic services.
- Generate meaningful validation evidence
- Develop studies aligned with intended use and clinical laboratory requirements.
- Support customer implementation
- Provide laboratories with structured implementation, validation and training support.
- Improve adoption of specialist technologies
RESEARCH AND ACADEMIC INTUITIONS
- Opitmisation validations and transitional phase validations
- Accelerate new service development
- Reduce barriers between product launch and successful clinical implementation.