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Skills

  • Failure Modes (FMEA)
  • Management
  • Medical Device Design
  • Regulatory Audits
  • Review Writing
  • Risk Management

Services

  • Medical Device Regulatory Affairs

    $40/hr Starting at $100 Ongoing

    Dedicated Resource

    Technical file preparation and review of medical device as per EUMDR 2017/745, gap assessment of QMS documents, QMS documents preparation and review for ISO 13485, 510k dossier preparation and review...

    Failure Modes (FMEA)ManagementMedical Device DesignRegulatory AuditsReview Writing