By: Satish Tiwari --
28 September, 2015
In month of July 2015, US congress approved of Cures act which aims at facilitating medical sector. This article is aimed at analyzing implications and concerns of this act in conjuncture with other acts such as UID. What does 21st Century Cures Act has for Medical Devices Sector
Breakthrough Medical Devices: Cures act aims at expediting innovation in this sector by promoting medical devices which can be categorised as "breakthrough technologies".
This act tries to differentiate between "Medical Software" and Health Software" wherein FDA can regulate the former.
This act aims at providing more clarifications regarding entities involved in sale and purchase of medical devices and taking measures to alert FDA to any counterfeit, misbranded or nonconforming devices in their possession. Author: Satish Tiwari
American Red Cross CPO will talk about the Art of Stakeholder Management on Aug 4