IVD Validation & Laboratory Quality Support
Clinical Validation | Analytical Validation | ISO 15189 | UKAS | IVDR | LDTs
Clinical Validation
Generate evidence demonstrating clinical performance and suitability for intended use.
Analytical Validation
Evaluate analytical performance using scientifically appropriate study designs.
Feasibility Studies
Determine whether an assay or methodology is viable before committing to full development.
ISO 15189 & UKAS
Support laboratories with validation, verification, implementation and accreditation requirements.
LDT & Modified IVD Support
Have you opened a new location, redesigned your shop, or added a new product or service? Don't keep it to yourself, let folks know.
Training
Practical training for laboratory professionals in quality, validation and regulatory requirements.
Request a Consultation
Whether you're implementing an IVD, developing an LDT, preparing for UKAS assessment or reviewing existing validation evidence, we can help you determine the appropriate next step.
Who ISOCHECKS helps
IVD Manufacturers
Laboratory Professionals
Clinical Laboratories
Clinical evaluation, analytical validation, feasibility studies and product development support.
Clinical Laboratories
Laboratory Professionals
Clinical Laboratories
ISO 15189 implementation, verification, validation, audit preparation and ongoing quality support.
Laboratory Professionals
Laboratory Professionals
Laboratory Professionals
Practical training in ISO 15189, IVDR, assay validation and specialist clinical sciences.
Need help with UKAS accreditation?
Preparing validation evidence for UKAS can be challenging. You need to demonstrate that examination procedures are appropriately selected, verified or validated, fit for their intended use and supported by clear, objective evidence ISOCHECKS helps laboratories develop robust validation strategies.