Duty Of Disclosure Considerations For Medical Device Patent Applicants With Parallel FDA Submissions
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 ...
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 ...
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.
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 ...
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