Qualityze - Blogs

Most people still picture an IVD as the little blue-and-pink pregnancy test in their bathroom drawer. Cute—but...

Good Manufacturing Practices (GMP) define the framework through which quality, safety, and consistency are bui...

In today’s precision-driven manufacturing world, not tracking a quality KPI in manufacturing industry is like ...

For quality and compliance leaders, audit readiness starts long before the regulator walks in. A non-conforman...

The FDA’s 510k and PMA pathways are not interchangeable in forms—they represent two fundamentally different ap...

Organizations in today's quality-focused world require more than intuitive gut-feeling problem solving; they r...

In manufacturing, a single quality lapse can spiral into a compliance crisis. That’s why quality control and a...

eCRF in clinical trials has revolutionized how data is collected, validated, and submitted. This guide explain...

In today’s fast-moving digital world, businesses are flooded with documents—policies, procedures, records, and...

If you imagine the FDA’s medical-device rulebook as a three-lane highway, Class II sits in the middle lane—dev...

Picture the last time you reached for a simple adhesive bandage or a manual stethoscope. Although these tools ...

From patient safety to global compliance, CAPA for medical devices industry supports every aspect of quality m...