Medical Devices Registration to South America

 

TSQ Asia with out experts network in the South America, can empower you in following different areas:

  • FDA 21 CFR Part 820
  • Product classification and registration services
  • Quality Management System (QMS) compliance strategy
  • Local representation services
  • Gap analysis of technical documents & quality systems
  • Regulatory support for product development documents such as Design History files
  • Regulatory support for technical file compilation
  • Regulatory and Market Intelligence support
  • Document and labeling translation support
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Sources of data/documentation utilized in a clinical evaluation can be gathered from:

    • Data generated through literature search 
    • Data generated through clinical experience 
    • Data from clinical investigations
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