Resources

This presentation will explore the critical challenges of data integrity and accessibility within the context of AI-powered, FDA-regulated medical devices. It will delve into the importance of robust and reliable...

This presentation will explore the critical challenges of data integrity and accessibility within the context of AI-powered, FDA-regulated medical devices. It will delve into the importance of robust and reliable...

This on-demand webinar explores the evolving cybersecurity requirements for medical devices under the U.S. FDA’s CDRH and the EU’s MDR and IVDR frameworks. It provides a detailed overview of the...

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...