Best of October: Top 5 Insights In Drug Formulation and Delivery

#1 - 5 Keys to Supplier/Purchasing Controls – And Product Quality

The growth of combination products in the market, as well as new quality and regulatory standards that apply to them, are driving the increased significance of suppliers. Fran DeGrazio lays out five foundational considerations for implementing an effective supplier/purchasing controls process.

#2 - Combination Products Regulatory Considerations with FDA's Barr Weiner

From his roles and experiences in the combination products and combined use systems arena, John “Barr” Weiner offers perspectives on how to approach pre- and post-market activities with regulatory requirements and guidance in mind.

#3 - A New Approach To ISO 14971 For Better Medical Device Risk Analysis

This article puts a new lens on the risk model in Annex C of ISO 14971 using relational risk analysis to describe a better approach for understanding and managing medical device risks.

#4 - Navigating PFAS "Forever Chemicals" In Medical Devices - What's On The Horizon

Gain an understanding of PFAS, their properties, environmental impact, health risks, and regulatory challenges, focusing on the specific implications for the medical device industry.

#5 - Improving Medical Device Testing With Robotic Automation

Recent high-profile failures and recalls of medical devices highlight concerns about patient safety. Robotic automation in verification testing can help with regard to precision, efficiency, and more.