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Need help with UKAS accreditation?
Get help from a UKAS trained consultant
New In-Vitro Diagnostics Regulation(IVDR) and ISO 15189, 2022 introduces new compliance challenges for manufacturers and testing laboratories using in-house devices
IVDR now makes concrete demands on laboratories using any laboratory developed test. A lot of medical laboratories are not fully aware of the existing and the new requirements
With a rapidly changing world of therapeutics a lot of devices do not have
clinical performance studies or clinical testing to correlate with the products stated 'intended use' provided with the IVD technical documentation
Verification process delays with Clinical laboratories trying to achieve ISO accreditation leaving new and better devices out of clinical use.
Pathology organizations adopting a multi-site hub and spoke model introduces new implementation challenges for laboratory management
Our team will support you as a medical laboratory in your adjustment to the IVDR and help ensure that you comply with the requirements for using LDTs whilst maintaining 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.
Send us the your data and we will analyse the data and compile the report to ISO 15189 requirements.
Review and or audit your processes before and perform jap analysis for SO 15189 accreditation.
Full assay/instrument implementation;
From planning and testing to full report write up. This is the hassle free product to the entire process enabling you to concrete on your day to day activities.
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.
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.
Premade validations sample packs delivered to conduct location evaluations of your procedure /instrument
Working with your install teams we will complete the analyser verification to ensure your client can go live with services as soon as possible and hassle free.
ISOChecks.co.uk