The audit standards for MDSAP (Medical Device Single Audit Program) certification in the United States are based on the following key regulatory frameworks and international standards:

1. FDA Quality System Regulation (QSR) - 21 CFR Part 820:

   • This is the primary standard for medical device manufacturers in the U.S. and forms the foundation of the audit. It covers all aspects of the Quality Management System (QMS), including design controls, production, process controls, and corrective and preventive actions (CAPA). The audit ensures compliance with these requirements.

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3. ISO 13485:2016:

   • This is the international standard for quality management systems specific to medical devices. MDSAP audits assess whether the manufacturer’s QMS aligns with ISO 13485, which is a broad standard recognized across multiple countries, including the U.S. It includes requirements for document control, risk management, supplier management, and more.

4. ISO 14971:2019 - Risk Management for Medical Devices:

   • MDSAP audits also assess compliance with ISO 14971, which defines the process for identifying and managing risks associated with medical devices. This includes risk analysis, evaluation, and mitigation strategies throughout the lifecycle of the device.

5. FDA Medical Device Reporting (MDR) - 21 CFR Part 803:

   • The MDSAP audit evaluates how the manufacturer complies with FDA regulations for reporting adverse events, device-related incidents, and field safety corrective actions (FSCAs). This ensures that there are systems in place for monitoring device safety and addressing potential issues promptly.

6. FDA Labeling Requirements - 21 CFR Part 801:

   • The audit checks that device labeling complies with FDA regulations, ensuring that the instructions for use (IFU), warnings, and claims are properly documented, and that the labeling contains all the required regulatory information.

7. FDA Postmarket Surveillance and Complaint Handling:

   • The audit examines how the manufacturer monitors the performance of their device after it enters the market. This includes handling complaints, conducting investigations, and ensuring that corrective actions are taken when necessary.

8. Internal Audits and Management Review:

   • The MDSAP audit includes reviewing the manufacturer’s internal audit process and management review records to ensure that the QMS is being effectively monitored and continuously improved.

9. Supply Chain and Supplier Management:

   • The audit assesses how the manufacturer manages its supply chain, including the selection and monitoring of suppliers, to ensure that materials, components, and outsourced services meet regulatory requirements and quality standards.

MDSAP audits are conducted to evaluate whether a medical device manufacturer’s processes and documentation are in full compliance with these standards, which ensure safety, effectiveness, and regulatory compliance for devices sold in participating countries, including the U.S.

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