Qualityze - Blogs

The EU MDR medical device classification system has its roots in Regulation (EU) 2017/745, which fundamentally...

An Electronic Document And Record Management System empowers organizations to manage critical documents with t...

Wondering what is 8D in CAPA investigations? Learn how this structured method helps uncover root causes, preve...

Have you ever wondered about the differences between “FDA cleared," “FDA approved,” and “FDA granted” when it ...

Have you ever wondered why some software applications function seamlessly while others are riddled with bugs a...

Imagine losing a million dollars over a missing signature – sounds dramatic? Yet it happens more than you woul...

Change is inevitable. Organizations that manage change effectively can adapt quickly, maintain compliance, and...

Healthcare is drowning in data—images, lab results, doctor’s notes, insurance forms, device feeds. Human teams...

What happens when a single missing signature on the shop-floor logbook ends up in a million-dollar recall?  ...

ISO audit can feel intimidating, but they don’t have to be. Think of them as an annual health check for your m...

Ever had your coffee maker sputter to a stop just as you’re pouring that first-thing-in-the-morning cup? You j...

Every industry wants fewer errors and better outcomes—and it begins with Safety and Quality Standards in QMS. ...