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Compliance and Regulatory Affairs

FDA / Third-Party Audit Support

FDA 483, Warning Letters, Other Agency Citations

Liaison with Regulatory Agencies

Global Premarket Submissions

U.S. Agent

Adverse Event Reporting

Recalls and Safety Alerts

Ad/Promo Regulation

U.S. Import/Export

FDA Establishment Registration / Device Listings

Quality Management Systems (QMS)

Corrective & Preventive Action (CAPA)

Complaint Handling

Design Controls

Risk Management

GMP Training

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Management Responsibility

Production and Process Control

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