Medical Device Biomaterials Supplier Liability Issues - FDA Regulation and Managing Risk

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.

Areas Covered in this Webinar:

• General supplier liability considerations
• Qualifying for the protections of the Biomaterials Access Assurance Act of 1998
• Supplier protection that may be available based on FDA’s review of the finished device
• Additional strategies biomaterials suppliers can consider to manage risk, including:
  • Contractual indemnification
  • Insurance provisions
  • Evaluating customers’ financial health
  • Other “soft” factors to assess

Who Will Benefit:

This webinar is intended for companies that supply components and raw materials to the medical device industry. Included are OEM manufacturers, chemical, glass and plastic manufacturers, electronics and electrical parts suppliers. The following personnel will benefit:

• In-house counsel
• Regulatory affairs managers
• Corporate risk managers
• Sales/marketing directors