We’re pleased to announce that BSI has accredited Lucid’s processes to ISO 13485 : 2003, the international standard for the development of medical devices.
For 10 years our industrial design and engineering team has been delivering medical device design. We’ve consistently used an evidence based approach, working to ISO 9001:2008. Customers drove our move to ISO 13485:2003 accreditation. As ours our team has been involved in the development of more invasive devices, the documentation of options and risk analysis has become more critical. We look forward to helping more clients with ISO 13485 medical device design.