Recalls and other field actions are an unavoidable part of the medical device industry. How manufacturers evaluate risks and manage recalls can make a significant difference in public safety and a company’s reputation and bottom line.
Conducting a health hazard evaluation (HHE) and the initiation, execution, and termination of a recall pose countless challenges. When is an HHE indicated? How does FDA’s HHE process differ from those used by industry? How does one estimate the probability or degree of risk – too often on the basis of incomplete information? What other factors should be considered? Who ought to be involved in evaluating the information and making the ultimate recall decision, then in overseeing the implementation of the process? What are best practices for external communications, and how does one determine that a recall is complete?
This two-day conference offers a unique opportunity to hear and interact with key FDA and industry experts on the thought processes, procedures, and practical issues involved in medical device recalls.
Presented as a hybrid event, plan to attend this conference in person, in Boston, MA or from your desktop.
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