After obtaining 510(k) clearance, medical device manufacturers must maintain strict compliance with the FDA Quality System Regulation (QSR, 21 CFR Part 820). FDA inspections can occur at any time and focus on ensuring that your quality management system, production processes, and corrective actions meet regulatory requirements. Being unprepared can result in warning letters, corrective actions, or delays in market distribution.

At XPRO AMERICA, we provide comprehensive inspection and audit readiness services, helping companies anticipate and address compliance gaps before FDA inspectors arrive. Our goal is to ensure that your organization is fully prepared, minimizing risk and maintaining uninterrupted market access.

Key Services:

• FDA QSR Audit Preparation: We conduct detailed reviews of your quality management system (QMS), including design controls, document management, production procedures, supplier controls, and complaint handling, ensuring alignment with 21 CFR Part 820 requirements.
• CAPA Planning: Corrective and Preventive Action (CAPA) programs are critical for addressing identified gaps and preventing recurrence. Our experts help implement effective CAPA processes, prepare documentation, and train teams for audit readiness.
• Mock Audits & Gap Analysis: XPRO AMERICA performs simulated FDA inspections to identify potential compliance issues, providing actionable recommendations to strengthen your processes and documentation.
• Regulatory Guidance & Training: We guide your internal teams on proper recordkeeping, deviation management, risk assessment, and response strategies for FDA inspections.

Why Choose XPRO AMERICA?

• Proven expertise in post-510(k) compliance and FDA QSR audits.
• Structured approach to CAPA implementation and documentation.
• Hands-on training for internal audit teams and management.
• Reduced risk of FDA citations or market interruptions.

By working with XPRO AMERICA, medical device companies can confidently navigate post-clearance regulatory obligations. Our proactive approach ensures that your organization is ready for FDA inspections and audits, maintains compliance with QSR standards, and safeguards product quality and patient safety.

XPRO AMERICA prepares medical device firms for FDA QSR audits, CAPA planning, and post-510(k) inspection readiness to ensure compliance.