International quality system standards due imminently
This article was originally published in Clinica
Executive Summary
International standards and related guidance for the design and manufacture of medical devices are well on the way, Ian Cutler, director of European regulatory affairs at Smith & Nephew, told delegates at the recent IBC conference in London on Design and Validation. Clinica notes that the international versions are modelled on European quality standards and guidance and may eventually be considered as suitable replacements for these (see issue No 735, p 3).