I am developing a new medical device. Do I always have to provide evidence of its medical benefits via a clinical evaluation? BEO BERLIN can take over responsibility for the clinical evaluation and clarify whether sufficient validation is available in the literature.
Standard in Focus: DIN EN ISO 10993-18
German version of EN ISO 10993-18:2020 Biological evaluation of medical devices – Part 18: Chemical characterisation of materials was published this month and replaces the version from 2009.
