Quality
Quality at APIS
Quality is at the forefront of the design, development, and production of our products and services. We follow and maintain an effective Quality Management System (QMS) and are ISO 13485:2016 and ISO/IEC 27001:2013 certified. In addition, we are FDA 21 CFR 820 compliant, and have Product Realisation procedures that adhere to CE-IVDR 2017/746 and UKCA- UK MDR 2002.
ISO 13485
In March 2023, APIS Assay Technologies received certification as continuing to operate a QMS which complies with the requirements of ISO 13485:2016 for the design, development manufacture and distribution of in vitro molecular diagnostic assays for detection of biomarkers linked to various human diseases and their therapy.
ISO 13485
In April 2020, APIS Assay Technologies received certification as operating a QMS which complies with the requirements of ISO 13485:2016 for the design and development of in vitro molecular diagnostic assays for detection of biomarkers linked to various human diseases and their therapy.
ISO 27001
In October 2021, APIS Assay Technologies received certification for the operation of an Information Security Management System which complies with the requirements of ISO/IEC 27001:2013 for all processes involved in the development of software solutions for the processing and analysis of medical data performed in Bioinformatics and IT; with the aim of leveraging the power of systems biology and big data to directly translate biomarkers into clinical utility.
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