Welcome to ICS
Biomedical Innovations & Consultancy Solutions
Diagnostic testing compliance & Validations Specialists
to meet
ISO 15189 2022 and In-house
IVD regulatory needs
How we help Manufacturers & Clinical Laboratories
We have holistic approach to improve patient care in diagnostic healthcare
Our team will support you as a medical laboratory in your adjustment to the IVDR and help you ensure that you comply with the requirements for using LDTs and accreditation against the ISO 15189 standards.
Knowing the clinical context of these requirements, effective application and dissemination of knowledge is critical to ensuring minimal harm to patient on an ongoing basis.
We train on the 'why' the standards are important in clinical context, providing case studies on how non-compliance leads to detrimental healthcare.
We also focus on training clinical teams to ensure they fully understand laboratory governance requirements.
featured Innovative Solutions for Tomorrow's Challenges
ISO15189 Accreditation solutions for Clinical laboratories
Lead times for implementation of devises or instruments in clinical laboratories can be an overwhelming task to incorporate within already busy schedules.
One of our specialist to take the hassle of the ISO 15189 accreditation process of any equipment or processes you require!
We provide from tailored solutions to full 'end to end' verifications or validations to ensure your laboratory meets the necessary standards and regulations to fulfil the requirements of ISO 15198,2022.
Specialist assays implementation
Set up testing for ADAMTS13 activity, antigen, open/close, IgG antibody and functional antibody assays for both clinical and research use.
Assays will be set up for direct user applications, accurately monitor patients on any Standard Of Care (SOC) or research therapeutics.
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
3rd Party Controls and Calibrators used in research projects
Used in Validation processes to provide assurances in production life cycle.
Custom made confirmatory ISO-Checks
controls, calibrators and manufactured products specific for research feasibility protocols in the diagnosis and monitoring for rare disorders.
Training and Development
- Introductory Haemostasis to Advance Haemostasis (Assay limitations & Diagnosis pathways).
- Quality assurances procedures.
- Assay development methods.
- Blood Morphology.
- Specialized Haemostasis methods- practical laboratory sessions.