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Medical quality compliance

$100/hr Starting at $25

FDA audit and remediation of DHF and DMR. Identify gaps in documentation (ISO 13485 and QSR). Verification and validation, process validation, risk analysis, risk management (ISO 14971).

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$100/hr Ongoing

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FDA audit and remediation of DHF and DMR. Identify gaps in documentation (ISO 13485 and QSR). Verification and validation, process validation, risk analysis, risk management (ISO 14971).

Skills & Expertise

AnalyticsCompliance ConsultingISO ComplianceManagementMedicalProcess DesignRisk AssessmentRisk ManagementValidation Engineering

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