The successful development of medical devices requires that the design be controlled to ensure product safety and that the device can fulfill its intended use. This course provides a practical understanding of the engineering value of design control throughout the product lifecycle as it pertains to product quality. You'll learn to use the nine elements of design control to make design objectives clearer, products more testable, and to better satisfy customer requirements, thereby shortening the path to product and business success. The course highlights the practical implementation of the design history file, reviews and records, transfer planning, requirements engineering and project planning. You will also learn topics related to design verification and validation testing, such as process validation, biocompatibility, shelf-life, sterilization and packaging validation.

Learning Outcomes

At the conclusion of the course, you should be able to

• Identify the key elements of the quality system (including Design Control) and ISO 13485.
• Explain the purpose of using Design Control from a regulatory and industry perspective.
• Discuss the nine elements of Design Control and its practical implementation.

Topics Include

• Design control, the quality system and ISO 13485: A brief introduction
• Design and development planning
• Design input, design output
• Design review and peer review
• Design change control
• Design transfer to manufacturing
• Design verification
• Design validation and use of statistics
• Design history file (DHF)

Additional Information

Students are expected to read the FDA Guidance on Design Control prior to the first class session.

FDA Guidance on Design Control (Links to an external site.) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers (Links to an external site.)

Professional Credit

Approved for 15 RAC recertification credits