Welcome to ICS Diagnostic Solutions
Biomedical Assay Development & Validation Services
To support transition of diagnostic innovations toward clinical use
ICS Diagnostic Solutions
ICS Diagnostic Solutions partners with In Vitro Diagnostics (IVD) manufacturers & developers, clinical research organizations and clinical laboratories in services & reagent component manufacturing to achieve accurate and reliable diagnostic results.
With laboratories and diagnostic professionals across disciplines in Blood sciences with specialists in Haemostasis, Haematology, Serology & Molecular diagnostics to support the needs of the clinical diagnostics industry, from early feasibility and research to commercial & laboratory development test (LDT) development, installation, validation and accreditation support.
We are a clinically run company incorporating the full ranges of specialist teams required to support new diagnostics to the market, optimize diagnostic processes and progress research and development. Please get in touch and see how we can collaborate to change the future of clinical diagnostics.
ICS Divisions
Our Specialist teams
With our expert guidance, navigate the complexities of ISO 15189 and IVDR regulations to ensure your diagnostic devise meets the highest standards of quality and compliance.
What we do
Clinical Validations
Service evaluations for diagnostic development
Quality Assurances Support
Compliance for Laboratory developed tests
Feasibility Studies
Defining clinical intended use of the IVD
UKAS accreditation support
Verification services for clinical laboratories
Collaborative Training
Skills to meet the evolving medical field demands
Diagnostic aid solutions
Production of Calibrators & Quality Control
New Services
Instrument Implementation & Verifications support
Instrument Verification for UKAS accreditation
In Collaboration with IVD manufacturers our team complete the verification process of any instrument installed for clinical use.
Services provided as part of the instrument installation process.
- Stage 1. Manufacturer Engineers will conduct installation (IQ).
- Stage 2. Manufacturer Product specialist performs operational qualification (OQ).
- Stage 3. Our UKAS support team will complete the performance qualification (PQ) and write report compliant to client's local protocol whilst ensuring compliance to to ISO15189, 2022 Verification requirements; 7.3.2 Verification of examination methods.
Why choose this service
We have a range sample types in our biobank and extensive clinical support to ensure verification of examination methods is fully compliant to ensure the validity of results pertinent to clinical decision making.
PQ will be fully completed ready for assessment from as little as 7 days saving your organization valuable time.
featured Innovative Solutions for Tomorrow's Challenges
Validation solutions
Premade validations sample packs delivered to conduct location evaluations of your procedure /instrument
- Normal Serum or plasma for normal ranges establishment
- Pathological samples for method comparison studies
- Spiked samples to evaluate treatment efficacy of methods
- Samples with interference substances to evaluate assay limitations
- Linearity and calibration verification products
Contact Us
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.
ISO-Checks.co.uk
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