• Length: 3:56
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Harvard i-lab | Understanding Medical Device Development

  • Length: 86:42
  • Rating Average: 4.875' max='5' min='1' numRaters='32' rel=' from people
  • View Count: 5342
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The healthcare industry is a hot bed of innovation. A convergence of new technologies, connectivity, big data and analytic models are creating a multitude of opportunities to improve health...

4.2 Regulatory Affairs Basics - Medical Devices

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  • View Count: 1914
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How to Get CE Mark Certification for Medical Devices Sold in Europe

  • Length: 10:49
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  • View Count: 17325
  • 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 preparation, ISO 13485 quality system ...

5 Mistakes Medical Device Startups Make

  • Length: 5:9
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  • View Count: 906
  • Author: Sterling Medical Devices

Tags: How can medical device startups avoid costly mistakes when navigating the FDA submission process to successfully bring their idea to market? Startups are...

FDA's Medical Device Innovation Initiative

  • Length: 53:5
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  • View Count: 31184
  • Author: USFoodandDrugAdmin


To ensure continued access to innovative medical devices, which often fulfill unmet public health needs, CDRH is launching the Medical Device Innovation Initiative, a comprehensive plan designed...

Risk management for medical devices - ISO 14971

  • Length: 5:33
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  • View Count: 9222
  • 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.

Global Distribution Strategies for Medical Devices (video)

  • Length: 66:22
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  • View Count: 1162
  • Author: TheEmergoGroup


Overview of how to set up medical device distributor relationships in global markets. Additional information available at

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