5 Building Blocks You Need for a Quality 4.0 Foundation
Market changes and disruptions such as the global pandemic are driving companies [...]
Market changes and disruptions such as the global pandemic are driving companies [...]
In the life science industry, adjustments are a necessary element throughout the [...]
This blog is the second of a three-part series on QMS implementation best practi [...]
We live in a world where speed is vital to success. Patients and consumers expe [...]
An efficiently designed change management system clearly defines how strategies, [...]
It’s World Quality Month (WQM) and that means taking time to reflect and recogni [...]
A trio of FDA 510(k) guidances demonstrate how important it is for medical device manufacturers to get a firm grip on document management and change control – especially when working within the Third Party (TP) Review Program or trying to determine if a medical device change warrants a new 510(k). The agency is attempting to make it easier on device makers if they understand how to work within the new system.