Unique Device Identification (UDI) is transforming how medical devices are tracked and monitored across their lifecycle. The system is...

The regulatory environment for medical devices has undergone a seismic shift in the last five years. One of the most profound changes is the new expectation that manufacturers must proactively and systematically monitor their devices once they reach the market. Gone are the days when post-market surveillance (PMS) simply meant collecting complaints and responding to adverse event reports. Today, regulators in the United States, Europe, and globally expect manufacturers to ope

AI and software are revolutionizing medtech, but regulators are raising the bar. In the U.S., FDA has finalized guidance on Predetermined...

The MDR and IVDR brought sweeping changes, but persistent bottlenecks led to deadline extensions. As of 2025, legacy devices benefit from...

In early 2024, the FDA finalized a historic overhaul of its medical device Quality System Regulation (QSR), marking the most significant...

In the ever-evolving arena of healthcare and pharmaceuticals, understanding the intricate landscape of life sciences regulations is...

The world of regulatory affairs and quality assurance (RA/QA) in the medical device sector is dynamic and often unpredictable.

Submitting a 510(k) application can be an intricate journey for medical device manufacturers.

In the fast-paced world of product development, staying on top of risk management files is crucial for compliance and product quality

In today's fast-paced world, hybrid and remote work arrangements are increasingly common, particularly in high-stakes industries like finance and pharmaceuticals.

The FDA's increasing interest in using real-world data (RWD) marks a significant development in the regulatory landscape.

Internal audit processes are often seen as dull repetitions filled with tick-box exercises.

In the increasingly complex world of medical device regulation, Unique Device Identification (UDI) compliance has become essential.

In the competitive world of medical devices and pharmaceuticals, getting your product to market can feel like navigating an obstacle course.

In the world of medical product development, understanding the regulatory landscape is crucial. One valuable tool that developers can...

Receiving a warning letter from regulatory bodies can be stressful, especially after a Form 483.

As the Food and Drug Administration (FDA) incorporates artificial intelligence (AI) into its inspection processes, companies in regulated industries must rethink their approach to data management.

The landscape of Clinical Evaluation Reports (CERs) is seeing a major shift as we approach 2025.

In the fast-paced world of clinical trials, choosing the right Clinical Research Organization (CRO) can make or break a project.

Navigating the complexities of a post-merger Quality Management System (QMS) integration can feel overwhelming. When two companies come...