Medical Device Biomaterials Supplier Liability Issues - FDA Regulation and Managing Risk
November 1, 2012 - Palo Alto CA US
This webinar on biomaterials supplier issues will cover strategies to minimize and manage the potential liability risks associated with supplying crucial materials to the medical device industry. It will cover statutory liability protections available for suppliers and how to manage risk based on FDA’s review of finished device. Why Should You Attend: Many companies are intrigued by the business potential of supplying components and raw materials to the medical device industry. However, these companies are also wary of the Food and Drug Administration's (FDA's) regulatory requirements and their potential liability exposure should a patient be harmed by the finished device, especially implants and other high-risk devices. This session is designed for specialty and commodity chemical/materials producers. It will provide an overview of FDA's regulation of device component/raw materials, explain the statutory liability protections in place for suppliers of materials for medical devices, and discuss other techniques for managing/limiting risk. The information presented here will allow suppliers to make better-informed decisions about entering the medical device market (or expanding their current participation to include new types of devices).