Medical Device Reporting (MDR) under 21 CFR Part 803 requires manufacturers, importers, and device user facilities to report adverse events and product problems to the FDA. Compliance with MDR regulations ensures patient safety, reduces liability, and supports timely FDA oversight.

At XPRO AMERICA, we provide end-to-end support for implementing a robust MDR system, handling adverse event reporting, and maintaining compliant complaint management processes for medical devices marketed in the United States.

Key Services:

• MDR System Setup: We design and implement an adverse event reporting system that meets FDA requirements, including data collection, reporting procedures, and timelines.
• Complaint Handling Support: XPRO AMERICA helps establish a complaint handling system to log, investigate, and resolve device complaints efficiently while maintaining complete documentation for FDA inspections.
• Adverse Event Reporting: Our team assists in preparing and submitting MDR reports to FDA, including death, serious injury, and malfunction events, ensuring compliance with reporting deadlines.
• Documentation & Record Maintenance: We maintain accurate MDR records, complaint files, and investigation reports to facilitate inspection readiness and regulatory audits.
• Regulatory Guidance & Updates: XPRO AMERICA provides ongoing support to stay compliant with FDA MDR guidance, regulatory updates, and evolving safety requirements.

Why Choose XPRO AMERICA?

• Expertise in MDR regulations and 21 CFR Part 803 compliance.
• Comprehensive support from system setup to reporting and recordkeeping.
• Minimizes regulatory risk and ensures timely reporting to FDA.
• Prepares companies for inspections and audits related to adverse events and complaints.

Partnering with XPRO AMERICA ensures that medical device manufacturers, importers, and distributors maintain full compliance with MDR regulations, implement effective complaint handling systems, and safeguard patient safety while meeting FDA reporting obligations.

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