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Medical Device CRO Blog

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New Audit Form for Medical Device Regulators

  
  
  
New Audit Form

The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from medical device regulatory authorities and the regulated industry. According to the website the purpose of the GHTF is to “encourage convergence in regulatory practices related to ensuring the safety, effectiveness / performance and quality of medical devices, promoting technological innovation and facilitating international trade. The primary way in which this purpose is accomplished is via the publication and dissemination of harmonized documents on basic regulatory practices.”

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