Quality Regulatory Specialists, Inc.

We focus on understanding your business goals to right-size your regulatory compliance strategy to enable business growth. Key areas of expertise: - Quality System Consulting - Regulatory Compliance Strategy - Quality Engineering - Medical Device Regulatory Impact Change Assessment - FDA 483 Inspection Responses - Quality & Regulatory Compliance Remediation - ISO 13485 - MDSAP - Risk Management (ISO 14971) - Document Control - Nonconformance Management (MRB) - Supplier Quality - Complaint Processing - Design Controls - Quality Objective / Goal Setting - FDA QSR/GMP/GxP - Adverse Event Reporting (MDR) - CAPA - Compliance Audits - Analysis of Data - Management Review - Quality Auditing - Statistical Reliability - Process Validation - Design Verification and Validation

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