Design control helps companies develop medical devices that meet user needs, intended uses, and specified requirements. Design issues account for nearly 40% of device recalls – more than double the next frequent cause – reason enough for more attention to this area. But compliance is not the only reason to build robust design control procedures. A competent design process that is coordinated with key functions from early product development through postmarket assessment provides tangible business advantages.
The iterative, interconnected nature of well-executed design control reveals deficiencies and discrepancies early in the product development process, and helps bridge the sometimes divergent and conflicting objectives of different groups within an organization. Feeding postmarket data back into the design process can lead to product improvement and additional product development.
In this highly interactive workshop, industry experts go beyond the basic principles and processes of design control to discuss the creation of a strong design control program that is well integrated into all relevant company functions and has the appreciation and support of business management.
Presented as a hybrid event, plan to attend this conference in person, in Washington DC or from your desktop.
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