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Regulatory Information

EDX Medical designs, develops, verifies, validates, distributes and supports a range of innovative digital diagnostic products and services for clinical use which are subject to regulatory requirements in UK, Europe, USA and key international markets.

We work on our own product programmes and with partners to run laboratory assays in our own or partner laboratories, provide test kits for 3rd party laboratories to provide such services, and deliver digitally-enabled Point of Care Devices for bedside use. Our products and services meet or exceed the requirements of the prevailing in-vitro diagnostics, medical devices, medical software and data security legislation in the relevant territories.

We are working in a rapidly changing market where our products and services are continually improving based on growing evidence, validated technical and clinical data, with medical and technical support in readiness for pending CE-IVDR regulations or equivalent around the world. Guaranteeing technical performance and clinical utility.

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The image shows the "edx medical" logo. "edx" is written in lowercase white letters inside a blue hexagon, with the word "medical" in blue lowercase text to the right of the hexagon.

The Scottish Prostate Cancer Initiative

EDX Medical is launching a new employee health screening service offering a comprehensive range of tests.