When a key RAQA leader resigns during a project, the impact can be significant and far-reaching. This shift can affect timelines,...

In 2024, the FDA inspected many facilities and issued Form 483 observations that pointed out significant compliance issues. These...

Introduction As EU medical device regulations evolve, companies must remain vigilant in ensuring their technical documentation aligns...

In the wake of the ever-evolving regulatory landscape, life science companies must be attentive to the various pathways that the FDA...

In today’s dynamic business landscape, uncertainty is a constant challenge. Every business, regardless of size or industry, faces a...

The Food and Drug Administration (FDA) has recently released a draft guidance document aimed at the healthcare and medical device...

The world of medical devices is rapidly evolving, bringing about remarkable advancements in how we diagnose, treat, and manage patient...

Post-market surveillance (PMS) is crucial for the ongoing safety and effectiveness of medical devices after they hit the market. As...

On June 4, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of Elsa , a new generative artificial intelligence (AI)...