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For MDSAP certification in the United States, the following documents are typically required:

1. Quality Management System (QMS) Documentation:

   • The complete QMS manual, including policies and procedures that align with FDA's 21 CFR Part 820 (QSR) and ISO 13485:2016.
   • Detailed procedures for design control, production, and process controls, as well as CAPA (Corrective and Preventive Actions).

2. Risk Management Documentation:

   • Documentation of the risk management process based on ISO 14971, which includes risk assessment and mitigation strategies for the medical device.

3. Product Technical File:

   • A file containing design and development information, including specifications, risk analysis, verification and validation results, and manufacturing information.

4. Device Labeling:

   • Product labeling, including instructions for use (IFU), warnings, and regulatory compliance statements required by the FDA under 21 CFR Part 801.

5. Medical Device Reporting (MDR) System:

   • Documentation outlining how the manufacturer complies with FDA's 21 CFR Part 803 for adverse event reporting.

6. Audit and Compliance Records:

   • Records from previous internal audits, external audits, and any corrective actions taken.

7. Management Review Records:

   • Records of senior management reviews that evaluate the effectiveness of the QMS and compliance with regulatory requirements.

These documents are essential to demonstrate that your company complies with both the FDA’s requirements and the international standards outlined in ISO 13485, which is the foundation of the MDSAP program.

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