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510k vs PMA Medical Device Approvals: What You Need to Know

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

How to Prevent Non-conformances in Quality Management

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

What Is IEC 62304: It’s Important in Med Device Compliance

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

How to Write an Effective Quality Investigation Report

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

Important Guidelines for Investigation in Pharma Industry

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

FDA Class 3 Medical Device: All You Need to Know

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

EU MDR Medical Device Classification: The Ultimate Guide

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

What is an Electronic Document And Record Management System

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

What is 8D? How To Use The 8D Method for CAPA Investigations

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

FDA Cleared vs Approved vs Granted: What You Need to Know

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

What Is Software Quality Assurance, and Why Is It Important

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

Audit Failure: Why It Happens And How To Prevent It

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

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