Nov 23, 2009 -
Medical Device Conference Wrap-Up: FDA Emphasis on Purchasing Controls
At a recent MiniTec half-day technical conference on medical devices, medical polymers, and emerging trends (co-sponsored by the Society of Plastics Engineers Philadelphia Section and Medical Plastics Division), a topic that generated many comments was the upcoming US FDA [Food and Drug Administration] emphasis on and scrutiny of purchasing controls for medical devices. Dr. Vinny Sastri, president of consulting company Winovia LLC, explained that FDA's philosophy has been evolving to an emphasis on risk management and purchasing controls of total quality systems for medical devices. In the total systems approach, companies need to understand the fundamentals of their products and processes throughout the product life cycle, and identify the sources of variation in both the raw materials and the process in order to have a "quality by design" approach.
