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

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 ...

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 ...

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 ...

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 ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

AI-assisted symptom recognition and pattern matching leverages machine learning to analyze vast amounts of medical data, including patient histories, clinical notes, and research publications, to ...

Cardiovascular diseases are responsible for over 15 million deaths worldwide per year. 1 The occlusion of vessels such as the coronary or peripheral arteries hinders the flow of blood to the heart, ...

This article discusses why Colombia, despite the global effects of the COVID-19 pandemic, has become the country with the best commercial advantages in South America and one of the three best in Latin ...