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Related Services

Regulatory Affairs and Related Services

Ethox International develops and maintains the following records, documents and services as a routine part of operation:

  • Device Master Records (DMR)
  • Device History Records (DHR)
  • 510(k), IDE, PMA consultation and preparation assistance
  • Minimum 5-year record retention
  • Lot certification/documentation packets
  • Routine documentation releases
  • Technical File development and assistance
© 2006 Ethox International. All Rights Reserved.