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

Discover Accumold’s micro molding expertise at COMPAMED 2025, where ultra-precision, scalability, and DfMM capabilities showcase how next-generation medical devices are enabled through unmatched ...

This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards. Here are practical tips to build ...

Over 25 years leading global quality and regulatory organizations, I've learned that the most difficult challenges aren't regulatory or technical; they're organizational and cultural. Mastering ...

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 ...

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 ...

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.

ArQ ® - Bios offers a small, simple to use package to deliver high viscosity formulations. Oval’s proprietary COC PDC technology allows us to build the device around a stronger drug container that can ...