Evolution of the Quality Management System - How to go from Surviving to Thriving

Learn from surviving to thriving of a Quality Management System

 

An efficient and effective Quality Management System (QMS) lies at the heart of a medical device company. Why do so many companies struggle to establish and maintain an efficient and effective QMS? Simple: not only is an efficient and effective QMS necessary to establish quality of the products; it is a regulatory requirement. Regulatory agencies such as the FDA lay heavy and overarching emphasis on a medical device company’ QMS.

At the other end of the spectrum, there are grave consequences to be suffered when a medical device organization fails to put in place an efficient and effective QMS. A weak and faulty QMS can lead all the way from medical device reports to FDA recalls, and from 483s to Warning Letters. And an inefficient QMS results in wasted time, money, and missed opportunities.

learn more