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MDR Consultants can help with:

  • QMS transition to the EU MDR or MDSAP
  • FDA 483 Response
  • Implementation of ISO 13485:2016
  • Implementation of ISO 14971:2019
  • Gap Analysis
  • Risk Management
  • Quality Management System Procedures
  • Technical File Generation and Maintenance
  • Post Market Surveillance (PMS)
  • Remediation Projects or Initiatives

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