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 ...

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 ...

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 ...

Medical device manufacturers have traditionally focused on designing devices that are safe and effective to use. This will continue to be the main concern, but there is now more pressure on ...

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 ...

The medical device market is diverse, fast-moving, and powered by dynamic customer needs and ongoing demand. Anticipated to reach $734.39 billion by 2027, the market is a land of both opportunity and ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...