The impact of new regulations and standards on the selection of polymeric biomaterials for medical components
By Mitsubishi Medical
Choosing the right biomaterial for a specific medical device application is a complex decision that involves not only technical and economic
considerations, but regulatory ones as well. This whitepaper discusses the role that biomaterial specification standards play in the choice of polymeric material for medical devices and highlights some of the current challenges associated with biomaterial selection in the context of medical device regulation.