As of 31st August 2021, Ubiquitome Ltd. is ISO 13485:2016 certified for its Quality Management System through BSI Group. As a company we control and are responsible for design and development, manufacturing, final testing, distribution, and handling of customer feedback for our Portable Real Time Device, which is now validated under the FDA Emergency Use Authorisation for the SalivaDirect Protocol.

Ubiquitome Ltd. is committed to developing and maintaining safe and effective diagnostic devices that consistently meet or exceed customers’ requirements. Ubiquitome Ltd. is committed to compliance with medical device regulations and requirements to ensure the effectiveness of the Quality Management System.

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View our ISO 13485 certificate.