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Medical Device CRO Blog

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21 CFR 312 vs. 812: What’s the Difference?

  
  
  
312 812 whats the difference

On Thursday, September 6th, BioEnterprise hosted an event at Corporate College in Cleveland, Ohio. The training event focused on the differences between investigational drug and medical device clinical trials.  Featured speakers for the event were Sandra Maddock, CEO and President of IMARC Research and Brandy Smith, Chief of Clinical Operations for IMARC Research.

Four Tips on Navigating the Regulatory Environment in Europe

  
  
  
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A MedCity News article provided four tips on how best to navigate the regulatory environment in Europe.  There is an increasing trend by medical device manufacturers to seek the European Union’s CE Mark for their initial regulatory approval.

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