In this 5-minute video, Kim Trautman, FDA’s Medical Device International Quality Systems Expert, speaks with Sangita Viswanathan, Editor-in-Chief, Medical Device Summit, on managing internal suppliers; benchmarking; and tackling global supply chain challenges. Trautman, who has been recently named FDA’s Acting Associate Director-International Affairs asks the device sector to: 1. Pay attention to internal suppliers; “a supplier is a supplier even if they are part of the same corporate structure, and you still need soundproof terms of agreement under QSR;” 2. Look at some best practices followed by automotive, telecommunications and aerospace sectors for risk management and supplier controls, and adapt these for consistent, better quality results; and 3. Work with FDA which has number of initiatives for managing global supply chain integrity and quality, and have the assurances in place to understand your supplier, manage risk and ensure a good quality product.
Video Rating: 5 / 5