US FDA medical device regulatory approval process overview

  • Length: 7:46
  • Rating Average: 4.6' max='5' min='1' numRaters='20' rel=' from people
  • View Count: 10695
  • Author: TheEmergoGroup


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
  • Rating Average: from people
  • View Count: 9445
  • Author: USFoodandDrugAdmin


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
  • Rating Average: 4.7894735' max='5' min='1' numRaters='38' rel=' from people
  • View Count: 6246
  • Author: World Health Organization


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
  • Rating Average: 4.6' max='5' min='1' numRaters='10' rel=' from people
  • View Count: 1236
  • Author: PBS


"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
  • Rating Average: 4.8095236' max='5' min='1' numRaters='21' rel=' from people
  • View Count: 13882
  • Author: TheEmergoGroup


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
  • Rating Average: 4.7' max='5' min='1' numRaters='40' rel=' from people
  • View Count: 5074
  • Author: CNN


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
  • Rating Average: 5.0' max='5' min='1' numRaters='3' rel=' from people
  • View Count: 977
  • Author: MedicalMarcom


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

  • Length: 5:33
  • Rating Average: 4.4666667' max='5' min='1' numRaters='15' rel=' from people
  • View Count: 4658
  • Author: Peter Sebelius


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

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