Resources

When a recall occurs the Regulatory Agencies such as the FDA require communication that is timely about corrective actions being taken by companies that FDA may consider have high-risk products....

Ensuring a successful product launch of a connected device requires that your supply chain be capable and available thru the different design and development stages. However, supplier quality management issues...

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:...