Audio Conference

Designing Devices in the Current Regulatory Climate Robert J. Klepinski Fredrikson & Byron Purchase recording US$199

Purchase recording of this audio conference

The current regulatory environment is dominated by post-market issues. Recent high-profile drug recalls have caused physician groups, Congress, the press and FDA to take new interest in post-market issues. To survive and prosper in this environment, medical device designers must recognize and accept several key truths.

Unlike drug molecular design, device design is an evolving process, not a one-time event. Also, a medical device is not just hardware, as the product labeling determines its use and its regulatory status. The associated service and customer care can make the difference between success and failure. Therefore, each post-market event causes you to look back into your design process; how far back and in what detail to do so are the key process issues.

This presentation will discuss the increase in post-market scrutiny, how it came about, and how device designers can best deal with it.

What this audio conference will cover:

• Designing devices with an eye to post-market issues
• How FDA & international standards are forcing expanded emphasis on managing risk
• Determining how much risk management is enough
• Developing a cyclical design control process

Speaker biography:

Robert Klepinski is an Officer with Fredrikson & Byron and practices in the Food and Drug Administration, Health Care Fraud & Compliance and Intellectual Property service areas. He is also recognized as one of the leading FDA compliance attorneys. He counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies on FDA policy. Previously, Robert served as a regulatory attorney for Medtronic. While there, he set the legal strategy for FDA compliance, including advertising and promotion, quality systems, regulatory and clinical.

Robert frequently speaks at both local and national trade associations on FDA policy. He has been an adjunct professor at the University of Minnesota Law School and a guest lecturer at other law schools, including Northwestern University, Hamline University and William Mitchell College of Law. He is currently an adjunct professor at St. Thomas University in its Graduate School of Engineering and its MBA program.

Who should attend?

• Medical device designers
• Product engineers
• Quality assurance
• Quality control
• Product development
• Regulatory affairs
• Management
  

Registration Options

• Purchase recording US$199