Clinical Laboratory Validation and Implementation Specialists
Clinical Validation | Analytical Validation | ISO 15189 | UKAS Support | IVDR | LDTs
Our services
Assay Validation for Manufacturers
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
Materials developed to support diagnostics including internal quality control (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 evidence of compliance with ISO 15189 requirements.
- Develop clear, comprehensive and traceable validation documentation.
- Build staff capability.
- Provide Training, competency support and knowledge transfer to your laboratory teams.
DIAGNOSTIC ASSAY MANUFACTURERS
- Understand the clinical laboratory environment.
- Gain practical insight into how your assay performs in routine clinical laboratory settings.
- 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 INSTITUTIONS
- Assay optimisation validations and transition-to-routine-service studies.
- Accelerate new service development.
- Reduce barriers between product launch and successful clinical implementation.