Abstract
Medical Device Document Writing - Correct Knowledge Process Outsourcing Partner will Be the Next-Gen Key to Success
Highlights
The medical device regulation is constantly evolving along with the evolving biomedical technology
Delay in the PCI device life cycle is directly linked with its shelf life and profits
This article is an attempt to focus on the various effects of regulations and their changes on the medical device regulatory documentation and propose solution on some solutions to mitigate them
Summary
Complementary and Alternative Medicine, India Submission: February 04, 2017; Published: February 13, 2017 *Corresponding author: Ashish Indani, Complementary and Alternative Medicine, India, Eamil: Introduction. The medical device regulation is constantly evolving along with the evolving biomedical technology. As a cascade phenomenon, such regulatory changes and additions impose binary effects the medical device industry. The negative side includes delay in documentation defers submission and as a consequence,often reduces the shelf life of thetechnology and its revenue premium. Among various contributors of such delay, one of the major contributor is regulatory process, mainly the time taken to compile and present a correct set of document. When a new regulation are implemented, various changes occur at ground level as in production floors, documents of operating procedures, quality management system etc. This article is an attempt to focus on the various effects of regulations and their changes on the medical device regulatory documentation and propose solution on some solutions to mitigate them
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
