In today's landscape of medical device development, regulatory compliance is essential. Efficiently documenting design changes is crucial...

In the fast-paced world of international business, navigating global regulations is crucial for success.

In today's tightly regulated landscape, the need for thorough technical files cannot be underestimated.

In the fast-changing world of medical device regulation, the European Union Medical Device Regulation (EU MDR) has set strict requirements for post-market surveillance (PMS).

Understanding the Impact of Leadership Turnover Leadership changes can create instability within a team, particularly in the complex...

Understanding FDA 483 Observations Form 483 is given by FDA inspectors when they see conditions in a facility that may violate FDA...

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The Food and Drug Administration (FDA) has recently released a draft guidance document aimed at the healthcare and medical device...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

In the wake of Brexit, the United Kingdom has created its own set of rules for different industries, including medical devices. The UK...

n the fast-paced world of medical device regulation, keeping up with changes is crucial. One of the most significant shifts is the FDA's introduction of the electronic Submission Template and Resource (eSTAR) for 510(k) submissions. This move aims to make the submission process smoother, increase clarity, and ultimately improve patient access to safe medical devices. For regulatory operations and quality leaders in medical device companies, understanding eSTAR's details i

The European Medical Device Regulation (EU MDR) continues to pose challenges for medical device manufacturers as they strive for compliance.

For medical device companies, compliance with international quality standards is essential to ensure product safety, regulatory approval, and market access.

Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing the medical device industry by enabling adaptive, data-driven...

Artificial Intelligence (AI) is rapidly transforming the pharmaceutical and biotechnology industries, offering powerful tools to accelerate drug discovery, enhance clinical trial efficiency, and optimize regulatory decision-making.

The pharmaceutical and biotech industries operate under intense regulatory scrutiny, with the U.S. Food and Drug Administration (FDA) ensuring compliance with Current Good Manufacturing Practices (cGMPs) and other regulatory requirements...