The presentation, using generic terminology, will provide an overview of a supplier’s approach to Applied Product Risk Assessment utilizing an internal proprietary system. The purpose of our Applied Product Risk Assessment process is to ensure that our products meet our corporate safety and legal standards, as well as all applicable safety, regulatory, and legal requirements in each country where the product will be marketed. Our internal global risk management process targets the identification and management of product related risk associated with raw materials, manufacturing, handling and distribution, sale, and the end-use of our products. The system is designed to broadly balance risk from multiple internal and external sources. Targeting increased institutional awareness and organizational decision-making at risk relevant levels, the process incorporates ad hoc risk review committees of technical professionals with backgrounds in toxicology & medical technology, legal, product development, manufacturing, and others as appropriate. Success has been achieved by embedding the product risk management process into our new product commercialization systems, creating a cultural change towards proactive consideration of critical risk management elements such as product risk, increased organization awareness, escalation of decision-making, and risk mitigation.