North Texas Biomedical Association




Quality System Concepts Needed for FDA's Medical

  • 11 Jan 2012
  • 11:00 AM - 1:00 PM
  • Internet

FDA’s regulation of Medical Device Data Systems (MDDS’s) applies to healthcare institutions  that develops an MDDS.  Effective April 2012, these institutions must comply with FDA’s Quality System Regulation.  While healthcare institutions have well-established organizations, few have a Quality System that complies with FDA’s specific requirements for developers of MDDS’s.  This webinar provides the building blocks for understanding and preparing for FDA’s Quality System Regulation.


  • Tammy M. Pelnik, President, The St. Vrain Group, Inc., Boulder, CO
  • Chas Burr, Graduate Program Director, Regulatory and Clinical Research Management, Regis College, Weston, MA


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