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ISOCHECKS

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Experts in Rare Disorder Assay Validation and Service implementation

Experts in Rare Disorder Assay Validation and Service implementation Experts in Rare Disorder Assay Validation and Service implementation Experts in Rare Disorder Assay Validation and Service implementation

 Clinical Validation | Analytical Validation | ISO 15189 | UKAS | IVDR | LDTs 

TALK TO AN EXPERT

Turning Innovation Into Routine Practice

 ISOCHECKS partners with laboratories and manufacturers to design, validate and implement high quality service for rare and complex blood coagulation disorders.

Our services

Assay Validation

Consultancy and Service implementation

Consultancy and Service implementation

Design and deliver analytical and clinical validation studies with robust reporting 

Find out more

Consultancy and Service implementation

Consultancy and Service implementation

Consultancy and Service implementation

Evaluate analytical performance. Strategic advise, business cases, service development.

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Products

Consultancy and Service implementation

Quality and accreditation

Material made to support diagnostics including IQC and calibrators capture antibody 

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Quality and accreditation

Quality and accreditation

Quality and accreditation

UKAS/ISO 15189 support, documentation, audits and compliance readiness

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LDT & Modified IVD Support

Quality and accreditation

LDT & Modified IVD Support

Using an Inhouse assay , or modified an assay?  find out how  we can help 

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Training

Quality and accreditation

LDT & Modified IVD Support

Practical training in quality, validation and regulatory requirements. 

Find out more

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.

Why work witth us

RARE DISORDER EXPERTISE

RARE DISORDER EXPERTISE

RARE DISORDER EXPERTISE

 Deep understanding of complex haemostasis and specialist diagnostic testing.

VALIDATION EXPERTISE

RARE DISORDER EXPERTISE

RARE DISORDER EXPERTISE

Analytical and clinical validation strategies designed for the intended use.

QUALITY DRIVEN

RARE DISORDER EXPERTISE

CLINICAL FOCUSD

A structured approach aligned with clinical laboratory quality requirements. 

CLINICAL FOCUSD

MANUFACTURER PARTNERSHIP

CLINICAL FOCUSD

Everything we do is ultimately focused on producing reliable results that support patient care.

MANUFACTURER PARTNERSHIP

MANUFACTURER PARTNERSHIP

MANUFACTURER PARTNERSHIP

 Independent technical support connecting manufacturers with clinical laboratories.

INNOVATIVE

MANUFACTURER PARTNERSHIP

MANUFACTURER PARTNERSHIP

Support the introduction of new technologies and novel diagnostics approaches 

Contact Us

Lets advance rare disorder diagnostics together

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Global services

We routinely cover services throughout UK and Europe. Slowly we growing in to other countries so we would love to hear from you no matter where you are located.

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ICS DIAGNOSTIC SOLUTIONS LIMITED

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