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Author: Bhanushree Tryambak
#5- Designing your product for FDA approval The example of 510k Premarket Notification Process
“Designing for FDA” is an essential part of any new product development process, which needs to be implemented 10 to 18 months before specific U.S. Market Entry and FDA submission plans are drafted. The Center for Devices and Radiological Health (CDRH) department of the Food and Drug Administration (FDA) has released Guidance for Industry on the 510(k) Premarket Notification Process …
#3 How to improve patient outcomes, while decreasing the cost of healthcare?
As a result of its huge cost, the U.S. Healthcare ecosystem is now seeking solutions that will (i) Increase Access to Care, (ii) decrease the cost of care and (iii) improve outcomes. In this post, we are going to focus on Improve outcomes The changes in the U.S. healthcare ecosystem to serve more patients and the cost/benefit of introduction of …