Compliance Management Events

  • FDA’s Two New Draft Guidance on Software and Device Changes and the 510(k)

    This session help you implement formal methods with documented and defensible rationale—which will prepare your organization for further 510(k) changes in the future, especially if your company is in the Medical Device and combination products fields. This is a long awaited clarification of U.S. FDA’s Memo K97-1 for medical device manufacturers, with far-reaching effects in regulatory compliance ...


  • Community Engineering Corps: Using Volunteer Expertise to Make an Impact in Small Systems

    Many communities across the United States have deficient infrastructure systems and struggle with regulatory compliance issues. The American Water Works Association, in alliance with the American Society of Civil Engineers and Engineers Without Borders USA, has developed a program to fulfill such communities’ need for help in addressing these concerns. This program, the Community Engineering ...


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