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MDR Consultants can help with:

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

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