Resources

The compounding pharmacy industry plays a critical role in modern healthcare by offering personalized medication solutions that mass manufacturers often cannot provide. But with this important role comes a complex...

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...

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (FDA’s CDRH) and the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have established...