Compliance with the FDA Quality System Regulation (QSR / 21 CFR Part 820) is critical for medical device manufacturers to ensure product safety, effectiveness, and regulatory adherence. The QSR outlines requirements for a Quality Management System (QMS), covering design controls, production, process validation, and corrective actions.

At XPRO AMERICA, we provide comprehensive services to help companies implement and maintain a FDA-compliant QMS, conduct internal audits, manage corrective and preventive actions (CAPA), and prepare for alignment with ISO 13485 standards.

Key Services:

• QMS Implementation & Compliance: We assist in establishing a robust QMS that meets FDA QSR requirements, including design controls, document management, supplier management, and risk management processes.
• Internal Audits & CAPA: XPRO AMERICA conducts internal audits to identify compliance gaps and implement Corrective and Preventive Actions (CAPA) to resolve deficiencies and ensure continuous improvement.
• ISO 13485 Harmonization: Our team guides companies in aligning their QMS with ISO 13485 standards, facilitating international certification and compliance harmonization for global market access.
• Documentation & Record Management: We ensure that all quality system documents, procedures, and records are maintained in compliance with FDA regulations and inspection readiness requirements.
• Inspection Preparedness: XPRO AMERICA prepares manufacturers for FDA inspections, providing guidance on QMS practices, CAPA documentation, and regulatory expectations to reduce non-compliance risk.

Why Choose XPRO AMERICA?

• Expertise in FDA QSR (21 CFR Part 820) and ISO 13485 standards.
• Comprehensive support from QMS design to audit and CAPA management.
• Minimizes regulatory risk and enhances product quality and compliance.
• Prepares companies for FDA inspections, audits, and international certification.

Partnering with XPRO AMERICA ensures that medical device manufacturers implement and maintain a fully compliant QMS, address compliance gaps, and harmonize processes with ISO 13485 standards. Our services streamline quality management, support inspection readiness, and promote continuous regulatory compliance.

XPRO AMERICA ensures FDA QSR compliance, internal audits, CAPA implementation, and ISO 13485 harmonization for medical device manufacturers.