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FDAnews Announces Medical Device Mobile Apps Virtual Conference - Oct. 3, 2013
Date:9/19/2013

ease out the fine points that can mean the difference between FDA approval and a warning letter. You'll discover:

  • What the FDA means when it uses the word health vs. wellness
  • What the FDA concept of intended use signifies
  • What constitutes an accessory, and which accessories does the FDA regulate?
  • Implications of the Biosence letter and the FDA's thinking going forward
  • The FDA's checklist for a successful approval — best practices and red flags every devicemaker must know
  • Obtaining FDA clearance — identifying and addressing safety-and-effectiveness criteria
  • The future of mobile medical apps: How you can work with the FDA to best serve patients
  • And much more

From fast-changing technology to regulatory parameters, conference chair Tim Gee is ideally positioned to shed light on the complexities. Mr. Gee boasts more than 20 years of in-depth research and experience helping medical device firms manage connectivity, and developing and obtaining FDA approval for medical-device apps.

Smartphone apps hold immense promise for devicemakers — and thorny new areas of regulation and law too, as the Biosense matter illustrates. On your way to innovation, don't let regulatory hazards trip you up. Get the answers you need — now.

Register now

Meet Your Faculty

  • Tim Gee, Principal and Founder of Medical Connectivity Consulting and a principal consultant with Santa Rosa Consulting. He boasts more than 25 years' experience with workflow automation via integration of medical devices with information systems and enabling technologies. Clients include healthcare providers, manufacturers and early-stage companies. Mr. Gee is 2012 recipient of t
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SOURCE FDAnews
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