Resources

In this article published by Pharmaceutical Technology®, Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discuss PDA/ANSI Standard 06-2025:...

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how...

Does your Quality Management System have the right capabilities to ensure that your XBU Connect Device will be safe and effective? Placing a connected device in the marketplace presents new...

This presentation will explore the intersection of Artificial Intelligence (AI) in medical devices and the FDA’s 510(k) premarket notification process. It will highlight and address the challenges posed by the...

Connected devices often feature complex system architectures with multiple components and subsystems, frequently developed by different teams. This session will highlight common pitfalls encountered during the development of connected devices—issues...

So you think you’ve got a connected medical device? Medical Device Regulators do not approve good ideas, they approve fully developed medical devices. This means that a working prototype and...