Understanding the crucial overlaps between FDA disclosures and patent law is important for medical device innovators seeking ...

Accumold will showcase its world-leading micro molding expertise at MEDevice Silicon Valley, Booth #1034, helping medtech innovators accelerate design, de-risk production, and achieve micron-level ...

In part 1 of this series, I explored how cultural intelligence forms the foundation for global quality and regulatory leadership. I examined why regulatory frameworks and quality systems are cultural ...

The medical device industry has gone global, but most quality and regulatory leaders still operate with regional mindsets. Leaders who master cultural intelligence build quality systems that leverage ...

Probability of harm (POH) is critical to appropriately scoring risks, so how should it be done? POH needs to show all probabilities, not suppress them.

Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of ...

Liquid Silicone Rubber (LSR) is redefining optical micro molding with superior durability, design flexibility, and thermal ...

Establishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure ...

Ready to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled ...