ABSTRACT
The complexity of applications and technologies in the medical device industry is enormous. Medical devices range from simple handheld tools to complex computercontrolled surgical machines, from implantable screws to artificial organs, from bloodglucose test strips to diagnostic imaging systems and laboratory test equipment. Given this complexity, it is no surprise that these devices are designed and manufactured by companies that not only vary in size and structure, but use different methods of design and development as well as management.
