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The MDSAP audit for medical device certification in the United States includes an evaluation of the manufacturer’s compliance with both FDA regulations and international standards. The key audit content typically covers the following areas:

1. Quality Management System (QMS):

   • The audit assesses whether the manufacturer's QMS complies with FDA's 21 CFR Part 820 (Quality System Regulation) and ISO 13485:2016. This includes evaluating processes such as document control, design control, production, and post-market surveillance.

2. Risk Management:

   • The audit reviews the company’s risk management process based on ISO 14971 to ensure that risks associated with the device are adequately identified, assessed, and mitigated throughout the device lifecycle.

3. Design and Development Controls:

   • The audit checks for compliance with design control requirements, ensuring that design and development activities are properly documented, validated, and verified according to regulatory requirements.

4. Manufacturing and Process Controls:

   • The manufacturer’s production processes, including quality control, are evaluated to ensure that devices are consistently manufactured to meet specifications. This includes the validation of manufacturing processes and control of equipment and facilities.

5. Corrective and Preventive Actions (CAPA):

   • The audit examines the CAPA system to ensure that the company has an effective process for identifying, investigating, and addressing nonconformities or potential issues with the devices.

6. Product Labeling:

   • The manufacturer’s labeling practices are evaluated to confirm compliance with FDA 21 CFR Part 801. This includes review of product instructions for use (IFU), warnings, and other labeling requirements.

7. Medical Device Reporting (MDR):

   • The audit checks that the manufacturer has a system in place to comply with FDA 21 CFR Part 803, which mandates reporting of adverse events and product problems.

8. Internal Audits and Management Reviews:

   • The audit reviews internal audit records and management reviews to ensure that the company is actively monitoring and improving its quality system.

9. Post-Market Surveillance:

   • The audit assesses the manufacturer’s procedures for monitoring the performance of the device after it has been placed on the market, including complaint handling and corrective actions.

The MDSAP audit is designed to ensure that manufacturers meet the regulatory requirements for all countries participating in MDSAP (including the United States), with an emphasis on a comprehensive, risk-based approach to quality management throughout the product lifecycle.

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