All "Quality Systems" articles

The right life sciences quality management system (QMS) can put your organization in a position to get to market quickly, scale fast, breeze through ...

A medical device quality plan is not only required by the FDA and the ISO 13485 framework, but it can help you build quality into your product and ...

Every day, three medical device quality managers open a piece of mail they will never forget. And these letters aren’t unforgettable in a good way. ...

Starting a medical device company is an immense task. You have plans to make, employees to hire, funding to obtain, and on top of all that, you have ...

We all know that quality management isn't a "set it and forget it system," but how do you actually make continuous improvement in quality management ...

When quality assurance in the pharmaceutical industry isn't prioritized, the results can be disastrous for the manufacturer and consumer. Imagine ...

Is your company vulnerable to recalls, reputational damage, and regulatory issues because of quality management process problems? A single major ...

Is a pharmaceutical quality policy just the necessary fine print that nobody reads? Not to industry leaders like Anders Vinther. Listen to the audio ...

Over one million companies around the world have passed ISO certification. So, don't let a quality management audit scare you to death. Many quality ...

Did you know that supplier quality management procedure issues have resulted in 1,111 citations by the FDA since 2008? 142 of those observances ...