Qualityze - Blogs

Have you ever used a medical device? If you are an adult, chances are high that you must have used one, whether invasive...

How much does preventing quality failures truly matter? It matters immensely. Preventing non-conformances in quality man...

IEC 62304 is an international standard that defines the life cycle requirements for medical device software. It provides...

A quality investigation report is a formal document that narrates the step-by-step inquiry into a specific quality event...

In the pharmaceutical industry, even minor anomalies aren’t just warning signs—they become immediate triggers for compli...

When it comes to medical devices, not all risks are created equal. Class III devices sit at the top of the risk ladder—t...

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

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

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

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

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

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