MEDICAL PRODUCT DESIGN CONTROL AND RISK MANAGEMENT.

Catalog description

This course presents a thorough description of the design control for medical device development, starting with documenting the product requirements and concluding with design verification and validation that the design output meets the design meets product specifications and user needs. The role and scope of standard operating procedures (SOP) and representative content of an SOP are described. The students are introduced to elements of design history file and documentation.