ISOCHECKS
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    • Home
    • Services
      • Validation Services
      • LDT Validations
      • Accreditation Services
      • Product Development
      • PT/EQA program
      • Training services
      • Online Ordering
    • about us
    • Further information
      • Regulation updates
      • Case Studies
      • Testimonials
      • Blog
      • Terms and Conditions
      • Privacy Policy
      • Modern Slavery Statement
ISOCHECKS

Signed in as:

filler@godaddy.com

  • Home
  • Services
    • Validation Services
    • LDT Validations
    • Accreditation Services
    • Product Development
    • PT/EQA program
    • Training services
    • Online Ordering
  • about us
  • Further information
    • Regulation updates
    • Case Studies
    • Testimonials
    • Blog
    • Terms and Conditions
    • Privacy Policy
    • Modern Slavery Statement

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About Us

Our Interest

Innovations is the lifeblood for diagnostic medical laboratories by turning scientific ideas into solutions contributing  to better outcomes and greater efficiency in healthcare.    

Our Goal

Our mission is to support manufacturers and clinical  laboratories by providing comprehensive evaluation services and products enabling testing with confidence & compliance.   

Our Team

A clinical lead group of healthcare colleagues who came together for one reason, improve diagnostics in healthcare and drive innovations projects.  

Background

ISOCHECKS trades under the name of ICS Diagnostic Solutions.

Our company partners with In Vitro Diagnostics (IVD) manufacturers & developers, clinical research organizations and clinical laboratories to provide an efficient user defined validations, optimization and feasibility studies to achieve accurate and reliable diagnostic results.   

With a dedicated Research and Innovations site located at central London, specializing in Haemostasis and blood sciences to support new diagnostics to the market, optimize diagnostic processes and progress research and development for the clinical diagnostics industry.

Our ISOCHECKS products are custom made to meet clinical and compliance requirements.

 We are a clinically run company incorporating the full ranges of diagnostic professionals so whether you require early feasibility studies to full analytical and clinical validations please get in touch and see how we can collaborate to change the future of clinical diagnostics. 

Get in Touch

our Core values

Clinical Lead Decision Making

Evolve with Regulations and Training needs

Collaborate and Listen to end users

Incentives we drive are based on current clinical information published in reputable medical journals and made by consultants and expert groups in the field.

A Manufacturers diagnostic product initially claimed  'intent of use' remains static despite changes in therapeutics. We find the japs of 'intended uses' and provide the solutions to ensure procedures remains compliant to any changes.

Collaborate and Listen to end users

Evolve with Regulations and Training needs

Collaborate and Listen to end users

Solutions and innovations are created by clinical, research associates and laboratory compliance teams.

Our team goals are to move research projects into clinical use in-line with IVDR requirements. 

We also aim to put systems live in the shortest time possible to enable  requirements for diagnostic's are put to clinical use without delay. 

Evolve with Regulations and Training needs

Evolve with Regulations and Training needs

Evolve with Regulations and Training needs

 Implementation and regulation of equipment and protocols in rare disorders where therapeutics is constantly evolving is the biggest challenge for laboratories today. We provide a team to overcome any compliance and regulations hurdles for inhouse process, help with the CE/UKCA marking validation processes, assist in accreditation and provide training (bespoke to meet customer needs).

how the process works

Make a request

To understand what is required and the gaps in either diagnostic IVDR  or ISO 15189 compliance, 

we take in your request and our administrators will compile the best team available to resolve your issues. 

A proposal  will be sent with timelines and personal assigned for your project and projected costs.

If you are happy with the proposal  we then proceed to deliver your request. 

Contact us

Payment

Products

A purchase order (PO) is required  for any orders placed. An invoice will only be sent after delivery of products ordered which is to be paid within 30 days to ICS Diagnostic Solutions Limited.


Services (any)

 As an ‘unincorporated member association, Individual consultants members are personally responsible for the work undertaken and contractual obligations between any of our customer.


Online training 

Payment is usually made online upon registration.

Sites we work with

Our collaborators

our Consultancy team

Consultancy team

All out team members work on a consultancy basis consisting of:

  • Current and retired clinical consultants
  • UKAS assessors
  • Specialist Nurses 
  • Registrars
  • PHD graduates  & Students 
  • Clinical scientists
  • Laboratory managers
  • Quality managers 
  • Clinical trials leads   

Recruitment

To make the best decisions and achieve our goals of improving and standardization of healthcare practices we only select professionals with the following criteria:


Clinical 

Publishing impact scores.

Authors in New England journal of medicine.

 Recognized as leads in their field.


Laboratory  management and Quality 

Proven history of change process. 

5+ validations undertaken. 

Experience in CE marking. 


Our Services

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Clinical Validations

Service evaluations for diagnostic development

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Analytical Validations

Method Comparison and Bias Estimation

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Feasibility Studies

Defining clinical intended use of the IVD

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Accreditation support

Compliance for Laboratory developed tests

#

Collaborative Training

Skills to meet the evolving medical field demands

#

ISOCHECKS Products

Production of Calibrators & Quality Control

  • Regulation updates
  • Terms and Conditions
  • Privacy Policy
  • Modern Slavery Statement

ICS DIAGNOSTIC SOLUTIONS LIMITED

Company Number 16678742

ISOChecks.co.uk

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