FDA's quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the ...

Planning ahead for design transfer and using it as a management tool results in a smoother, less costly transition from development to production. Terry Zenner It has become popular to say that all ...

Have you ever thought about how and why something was designed? Who was considered a “stakeholder” for the design? And what biases are baked within the process of designing something? These are some ...