Towards an evidence based medical device introduction?
Door wilco op vr, 03/13/2015 - 06:59Medical devices, and particularly their introduction into the healthcare system are under scrutiny. Recent adverse experiences with devices such as the metal-metal hip implant and the PIP implant have accelerated the public awareness that there is insufficient safeguard against possible side effects of innovative medical devices. After a national broadcast of a consumer program revealing the ease to acquire a CE mark, the Dutch ministry of health was triggered to inform the parliament about new regulations to prevent future disasters.