Laboratory Facilities

ITL’s laboratory facilities provide a service to both the Design and Development Department and to the Manufacturing facility.

The laboratory is run in accordance with GLP and ISO accreditation and is involved from the design concept through the proof-of-design phase and ultimately to final Customer Acceptance.

Development

Experienced personnel contribute to the understanding of the chemistry / instrument interface and help define the test parameters and methods at each stage. They work on the validation of results from basic sub-assemblies to the final integrated instrument, using chemical, photometrical and biochemical methods. All methods are referenced to calibrated equipment. In addition the laboratory is responsible for the integration of established assay chemistry to automation, and for comparison of non-automated system results. Although we do not undertake full clinical trials, we are experienced in providing supporting data for 510(K) submission for FDA approval of IVD systems.

Quality Control and Customer Acceptance

Our main aim is to provide you with a validated fit-for-purpose instrument. The laboratory personnel work in conjunction with you to ensure that the test criteria are appropriately defined and statistically relevant; these techniques are then agreed and implemented. The laboratory will act on your behalf ensuring that the acceptance criteria are met by each instrument prior to release.