US FDA medical device regulatory approval process overview

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  • View Count: 10695
  • Author: TheEmergoGroup

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Provides a short high level overview of the US FDA medical device regulatory approval process. Talks about device classification, 510(k) applications, GMP qu...

Idea to IDE: A Medical Device in the Making

  • Length: 10:29
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  • View Count: 9445
  • Author: USFoodandDrugAdmin

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Most medical device inventions start out as a single great idea, but how does that idea become a marketed medical device? This video provides a brief overvie...

WHO: The power and potential of medical devices

  • Length: 7:13
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  • View Count: 6246
  • Author: World Health Organization

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This video highlights the importance of medical devices to health care and reviews the challenges and way forward for improving access to medical devices. fo...

Need to Know: Medical Device Safety

  • Length: 25:16
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  • View Count: 1236
  • Author: PBS

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"Need to Know" medical correspondent Dr. Emily Senay examines whether the Food and Drug Administration's medical device review process is adequately protecti...

How to Get CE Mark Certification for Medical Devices Sold in Europe

  • Length: 10:49
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  • View Count: 13882
  • Author: TheEmergoGroup

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Explains the European CE Marking process and how to get a medical device approved for sale in the EU. Explains device classification, Technical File preparat...

Why toys make good medical devices

  • Length: 3:34
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  • View Count: 5074
  • Author: CNN

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Jose Gomez-Marquez of MIT's Little Devices Group hacks toys to make affordable medical devices for developing countries.

Medical Device Companies Growth

  • Length: 52:59
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  • View Count: 977
  • Author: MedicalMarcom

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Medical Device Company Executives Tom McCall (Chief Marketing Officer, ICU Medical), Jim Buck (President & CEO, Mardil Medical), Steve Ogilvie (VP of Corpora...

Risk management for medical devices - ISO 14971

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  • View Count: 4658
  • Author: Peter Sebelius

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See a one hour FREE course on the same topic on www.gantus.com/iso14971. A short introduction to risk management for medical devices according to ISO 14971.

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