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Docobo’s accreditation for ISO EN13485:2016 for medical devices is extended for a further 3 years

Docobo has once again been successful in its recent British Standards’ Institute Quality Management System (QMS) audit for medical devices – ISO EN13485:2016.

Accreditation requires that every three years Docobo undergoes an extensive audit. Having an accredited quality system means that the telehealth products and services that Docobo provides consistently meet the NHS’s high standards and regulatory requirements. Docobo’s DOC@HOME remote monitoring solution is classified as a Class 1 Medical Device and its hugely successful CAREPORTAL (Docobo’s fit for purpose patient monitoring device) is a Class 2a Medical Device.

ISO EN13485:2016 is an internationally agreed standard, specifically created for the safety and risk critical medical devices industry. It was written to support medical device manufacturers ensure their quality management systems establish and maintain the effectiveness of their processes.

This means that - in maintaining our high standards of safety and quality - our customers can continue to work, safe in the knowledge that our products are fit for purpose and are medically and legally compliant for use across the NHS."

Adrian FlowerdayManaging Director, Docobo