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ISO 13485 recertification for medical device design and manufacture

Writer's picture: Jan Hon WongJan Hon Wong

Updated: 4 days ago

Helping ambitious organisations deliver life enhancing design requires innovation, creativity, know-how and, above all, trust.




At Lucid, we hold ourselves to the highest standards. Since 2012 Lucid has been certified for medical device design to ISO 13485, the medical device industry’s quality management system (QMS) harmonised standard, and in 2018 achieved certification for medical device manufacturing, too.


Last week we achieved BSI recertification for both design and manufacture, with zero nonconformities.


In the highly regulated sectors Lucid clients specialise in, achieving a third BSI audited reaccreditation for ISO 13485 medical device design and manufacturing is an essential external validation of our team’s know-how and experience.


Need to develop digital, physical or connected devices to the highest standard?


Be it MedTech, wellness or life safety - we’re here to help.


Being certified to ISO 13485 for medical device design and manufacture demonstrates Lucid Group upholds the highest standards.




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