Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approachinstruction manual statements that present the risk of user error and misuse. Companies should also bear in mind that FDA acceptance or approval of labeling/instructional materials will not provide an absolute shield of protection in productanbsp;...
|Title||:||The Medical Device Industry|
|Author||:||Norman F. Estrin|
|Publisher||:||CRC Press - 1990-08-31|