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 discusses the increase in post-market scrutiny, how it came about, and how device designers can best deal with it.
Device Design in the Current Regulatory Climate was presented by Robert J. Klepinski, with Fredrikson & Byron and is previously recorded. For more details, or to download this event please visit our site at www.fxconferences.com
