Course Dates Upcoming Dates and Locations Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times. There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!
Course Details Objectives Understand the requirements of ISO 13485:2016. Apply process-based thinking to an ISO 13485-compliant quality management system. Understand what is and is not a medical device, and how medical devices are classified and regulated. Establish the relationship of ISO 13485 to ISO 9001 and the FDA Quality System Regulation 21CFR820. Review the QMS requirements in the ISO 13485:2016 standard. Plan the activities of a registration audit. Topics The role of the quality management system The process approach to quality management systems ISO 13485 background ISO 13485:2016 requirements: clause by clause ISO 13485 registration Who Should Attend This course is appropriate for anyone who needs to know how to meet the requirements of ISO 13485, including management representatives; RA/QA managers/engineers; internal auditors; compliance and legal; product, project, and program managers; R&D or engineering managers; and other cross-functional team members. Virtual Half-Days In-Person Full-Days CEUs 1.5