Development and validation of diagnostic tests
Our Facility is overseen by our Laboratory and Production Manager, Katrina Seaton. As a Health and Care Professions Council (HCPC) registered Biomedical Scientist (Registration Number BS63571), Katrina’s expertise ensures the high quality of all test results; overseeing blood collection kit and ELISA test manufacturing, blood testing and quality control processes giving you the peace of mind that your test results are accurate and quality assured.
Our laboratory houses state of the art equipment including enzyme-linked immunosorbent assay (ELISA) manufacturing and testing equipment, CE marked allergy testing equipment and gold standard HPLC equipment for homocysteine measurement.
Underpinning all our operations, the company is accredited to ISO13485:2016. This demonstrates our ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements.
We are audited annually by SGS who are a representative of the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
All our blood collection kits are assembled to Medical Device Regulation (EU) 2017/745 Article 22 standards. All individual medical devices (e.g. lancets, plasters, cleansing wipes and sample collection containers) are CE marked.