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 control of design and development and their role in the regulated medical device industry. Review and compare design control in the QSR and ISO 13485. Understand the "process model" approach to design control. Identify the individual elements of the design control process. Understand the phases of the product life cycle and their relation to design control. Learn how to structure design control using good project management techniques. Build a successful design control team. Recognize the proper use of postproduction information in design control. Learn the expectations of the FDA and its QSIT approach to inspection in relation to design control. Topics FDA, ISO, and design control Key terms and definitions Principles of the "process model" Overview of the design control process model The design control team Product life cycle and design control Design control, risk management, and CAPA Building the compliant design history file (DHF) QSIT and design control Who Should Attend Anyone managing, developing, or engaging in the design of medical devices, including direct engineering functions, QA/QC, production management, regulatory, and any others that have a role in building a robust regulatory compliant environment. Related Courses Risk Management and Analysis for Medical Devices Developing and Maintaining a Compliant Document Management System Implementing CAPA Programs for the Medical Device Industry Root Cause Analysis for Life Science Investigations Virtual Half-Days In-Person Full-Days CEUs 1.5