More in Regulatory

  • Dec 12, 2012
    blog

    Device recalls and corrections: establish strategies and be prepared

    In this guest blog, Cheryl Shea-Frederick, Director, Regulatory Affairs at ArthroCare Corporation, who will be speaking at the marcus evans Medical Device Safety Monitoring and Reporting event in Las Vegas January 17-18, 2013, shares her thoughts on ......More
  • Nov 12, 2012
    blog

    The election is over: how does it affect FDA and you?

    With the election now over, the shape of the administration and of the 113th Congress remain largely unchanged. But some new faces will be in the mix, and the election results mean that legislation left hanging can move forward. John R. Manthei, a ......More
  • Oct 18, 2012
    blog

    Guest blog: Monitoring the safety of post-market medical devices

    In this guest blog, Tatyana Chorny, Regulatory Affairs, Post-Market Surveillance & Complaints Management at Philips Healthcare, who will be speaking at the marcus evans Medical Device Safety Monitoring and Reporting event in Las Vegas January 17-18, ......More
  • Aug 28, 2012
    blog

    Hazard analysis as function of quality management in medical design

    By Tim Lozier, EtQ Life is full of “what ifs.” “What if I didn't turn left instead of right,” “What if I hadn't taken that job,” “What if I ordered a venti instead of a grande.” We always look back on our decisions and wonder what would have ......More

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