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 ...

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

Anyone who has been doing risk management for medical devices or combination products is familiar with the ISO 14971:2019 and ISO/TR 24971:2020 standards. These recognized standards describe a risk ...

Cleanroom micro molding ensures ultra-small components meet strict contamination and performance standards. As devices shrink ...

ArQ ® - Vita can achieve large volume, deep intramuscular delivery, making it the ideal platform to deliver medication for chronic conditions. Built around Oval’s polymeric primary drug container ...

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 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 ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

This article is the first of a two-part series; read part two here. The U.S. Food and Drug Administration (FDA) is increasing demands [i],[ii] for drug delivery device developers to demonstrate the ...