IVDR support for IVD manufacturers
The introduction of the In Vitro Diagnostic Regulation (IVDR 2017/746) has significantly increased the clinical evidence and performance evaluation requirements for diagnostic manufacturers.
ISOCHECKS supports organisations throughout the IVDR journey by providing:
Performance Evaluation Planning
- Scientific validity assessment
- Analytical performance evaluation studies
- Clinical performance studies
- Performance Evaluation Plans (PEP)
- Performance Evaluation Reports (PER)
Clinical Evidence Generation
- Clinical study design
- Method comparison studies
- Interference and robustness testing
- Precision, accuracy and reproducibility assessments
- Clinical utility studies
- Real-world performance evaluations
Technical Documentation Support
- Validation strategy development
- Clinical evidence gap analysis
- Regulatory risk assessments
- Support for Technical File submissions
- Documentation review against IVDR requirements
Specialist Expertise for Higher-Risk IVDs
- Haemostasis and coagulation assays
- ADAMTS13 diagnostic testing
- Thrombosis biomarkers
- Point-of-care diagnostics
- Rare disease diagnostics
- Companion and prognostic biomarkers
Our approach
01 — Understand
We establish the intended use, clinical application, method characteristics and laboratory requirements.
02 — Design
We develop a validation or verification strategy appropriate to the method, risks and intended use.
03 — Execute
We support with study implementation, clinical samples, testing and data collection.
04 — Analyse
We review the results using appropriate statistical and scientific approaches.
05 — Document
We produce clear evidence and conclusions that demonstrate whether the method is fit for its intended purpose.
06 — Implement
We help you translate the findings into your laboratory's implementation and quality documentation.
BITE SIZE VALIDATIONS
Feasibility Studies
From £2,500
We start by understanding exactly what the test is intended to do. This includes:
- Patient population
- Specimen type
- Clinical indication
- Reporting requirements
- Decision points
- Laboratory workflow
- Demonstrate proof of concept
Clinical Performance
From £7,000
Assesses the ability of the assay to support clinical decision-making in the target patient population. Includes:
- Clinical sensitivity and specificity
- Predictive value
- Correlation with clinical outcomes
- Performance in relevant disease cohorts
Analytical Performance
From£4,000
Evaluates the technical characteristics of the assay, including:
- Precision (repeatability and reproducibility)
- Accuracy and bias
- Linearity and measuring range
- Sensitivity and detection limits
- Specificity and interference studies
- Stability of reagents and samples
Method Comparison and Bias Estimation
£5,000 - £15,000
Compares results obtained with the new assay against an established reference or comparator method. Evaluates:
- Agreement and correlation
- Systematic and proportional bias
- Concordance of clinical interpretation
- Analyze at least 40 samples as CLSI EP9-A2 recommendations.
Robustness
£3,000 - £12,000
Determines the reliability of the assay under expected variations in routine use, including:
- Operator-to-operator variation
- Reagent lot variation
- Environmental conditions
- Instrument and workflow variations
Minimum of 80 data points used in this study.
Interference Studies
£4,000 - £10,000
Defined assay limitations and acceptable operating conditions.
- Haemolysis
- Icterus
- Lipaemia
- Rheumatoid factor
- Heterophilic antibodies
- Anticoagulants
- Drug interference
Validation support
Sample and study design
Prices from £175
We can help develop practical study designs incorporating:
- Patient samples
- Normal donor samples
- Residual clinical specimens
- Archived material where appropriate
- Low-activity samples
- Positive samples
- Negative samples
- Inhibitor-positive material
- Challenging clinical samples
- Dilution studies
- Spiking studies where appropriate
We help you obtain maximum value from every sample
Validation sample packs
Prices from £100
Packs available:
- 40x acute TTP with <10% ADAMTS13 levels.
- 100x full range of ADAMTS13 result from 1%- 120%.
- 40x low coagulation factor samples.
- 40/100 pack of serum samples for a range biochemical markers.
- Or request a custom made set.
- Prices are dependent of study size and complexity of requirements
All prices displayed on this website are provided for guidance only and should be considered indicative estimates. Final costs are determined following review of the project scope, assay complexity, sample numbers, statistical requirements, reporting needs, timelines, and resource availability. Quotations are provided on a case-by-case basis and may vary from the ranges shown. Academic, NHS, charitable, and collaborative research projects may qualify for preferential pricing. All prices are exclusive of VAT unless otherwise stated.
Validation centre
Install Your Instrument at Our London Research Facility
- Evaluate your technology in a real-world clinical research environment. Our Central London Research & Innovation Centre provides manufacturers with access to specialist laboratory expertise, enabling instrument installation, feasibility studies, assay optimization, validation, and performance assessments.
- By partnering with ICS Diagnostic Solutions, you can generate robust clinical evidence, refine workflows, and accelerate the path from development to clinical implementation.
Benefits
- Dedicated research laboratory facilities
- Specialist expertise in haemostasis and blood sciences
- Feasibility and validation studies
- Independent performance evaluation
- Support for IVDR and regulatory requirements
- Fast-track clinical implementation strategies
Install. Evaluate. Validate. Innovate.