This course is relevant to manufacturers of medical devices, including IVDs, particularly staff and managers in areas of quality, regulatory affairs, technical managers, and those responsible for technical files.
Participants are expected to have basic knowledge of ISO 9001:2008 and ISO 13485:2003 quality management system standards prior to attending this course.
Note: SGS shall provide only generic information and advice which are freely available in the public domain.
SGS will not provide company-specific advice towards any development and implementation of managements systems for eventual certification, which contravenes requirements of the IAF Guidance (i.e. provision of consultancy services).