This 90-minute webinar will help you understand the competence and training requirements in the Quality Management Systems for medical devices, especially FDA QSR, ISO 13485, and even ISO 9001.
FDA QSR states, “Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.” The corresponding requirement in ISO 13485 and ISO 9001, says, “Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills, and experience”.