Medical device manufacturers face unique and challenging issues when it comes to product quality, regulatory and standards compliance, and defect tracking. Because the products made by these companies address human health and wellbeing, and are often implanted or used in the body, there is no room for device failure or non-compliance where lives are at stake.
Facing ever-increasing regulation and scrutiny by the U.S. Food and Drug Administration, medical device manufacturers need cost-effective ways to monitor their manufacturing processes and test their products. Today’s de facto standard, batch destructive testing, is expensive, reduces yields and, ultimately, fails to certify that every part conforms to standard.
There is a better way, one that eliminates destructive testing, brings more accuracy to the manufacturing process and reduces costs. Quality monitoring during the manufacturing process of medical devices delivers these benefits and more.
Key to this approach is the capture of a process signature that provides manufacturers with real-time, actionable data from the plant floor. Using process signatures, manufacturers collect the precise signature of all critical elements of the manufacturing process, allowing them to know instantly when a defect occurs in any part and to easily determine and fix root causes. If a defective product makes it into circulation, manufacturers using this quality management methodology can quickly find and fix the problem, prove how it has been corrected, and get their production lines running again.
The following White Paper provides useful information about how to move away from ineffective, expensive testing methods while reducing costs and improving quality.