In the MDSAP (Medical Device Single Audit Program) registration process for medical devices in the United States, auditors play a crucial role in assessing the manufacturer’s compliance with regulatory requirements across multiple countries, including the U.S. (FDA), Canada, Brazil, Japan, and Australia. The responsibilities of MDSAP auditors are detailed and focused on ensuring that the manufacturer's Quality Management System (QMS) aligns with the standards and regulations of these jurisdictions. Below are the key responsibilities of auditors in the MDSAP process:

1. Planning and Preparation for the Audit

• Audit Scope and Objectives: Auditors must work with the manufacturer to define the scope of the audit. This includes identifying the products, processes, and locations that will be included in the audit.
• Audit Schedule: Auditors are responsible for planning the audit schedule, including determining the time required to assess the manufacturer’s QMS and arranging for the necessary resources (e.g., additional auditors or specialists if needed).

2. Reviewing Documentation

• Pre-Audit Documentation: Auditors must review the manufacturer's documentation before the audit to ensure that the necessary records are in place. This includes reviewing the company's QMS, previous audit reports, and compliance with ISO 13485 and FDA regulations (21 CFR Part 820).
• Document Review During the Audit: During the on-site audit, auditors evaluate the company’s QMS documentation, including design controls, production records, complaint handling, risk management, and post-market surveillance data.

3. Conducting the On-Site Audit

• Assessment of Compliance: Auditors assess the manufacturer’s compliance with the relevant regulations (ISO 13485, FDA 21 CFR Part 820, and the regulations of other MDSAP jurisdictions). They conduct interviews with personnel, observe manufacturing processes, and inspect facilities to verify that the QMS is effectively implemented.
• Auditing Procedures and Processes: Auditors evaluate key processes, including but not limited to:
  • Document control
  • Risk management
  • Design and development controls
  • Supplier and subcontractor management
  • Nonconformity management and corrective actions
  • Post-market surveillance and reporting of adverse events
• Identifying Nonconformities: If any nonconformities are found during the audit, auditors document and categorize them. They must assess the severity of the nonconformities, whether they impact product safety or compliance, and whether they are systemic or isolated issues.

4. Interviews and Observations

• Staff Interviews: Auditors interview key personnel, including top management, quality control staff, production managers, and other relevant individuals, to assess their understanding and implementation of the QMS requirements.
• Observing Practices: Auditors observe the manufacturer’s operations, including production processes, equipment maintenance, and handling of quality control activities, to verify that they align with documented procedures and regulatory requirements.

5. Reporting Audit Findings

• Audit Report Preparation: After the audit, auditors prepare an audit report that summarizes their findings. This report includes a detailed analysis of the manufacturer’s compliance with applicable standards and regulations. It also includes any nonconformities found during the audit and the severity of each issue.
• Nonconformity Classification: Auditors classify nonconformities into different levels (minor, major, or critical) based on their potential impact on patient safety and regulatory compliance.
• Recommendations and Corrective Actions: Auditors provide recommendations for corrective actions if nonconformities are identified. They also evaluate whether the manufacturer has already taken appropriate corrective actions or whether additional measures are needed.

6. Follow-Up and Verification of Corrective Actions

• Corrective Action Plans: If nonconformities are identified, auditors review the manufacturer’s corrective action plans and assess their adequacy. The manufacturer must implement corrective actions to resolve any issues before certification is granted.
• Verification of Corrective Actions: In some cases, auditors may follow up with the manufacturer to verify that corrective actions have been implemented effectively. This may involve a second review or additional documentation.

7. Issuing the Final MDSAP Report and Certificate

• Final Audit Report: Auditors prepare a final audit report based on their findings and submit it to the MDSAP-recognized auditing organization. This report serves as the basis for determining whether the manufacturer meets the compliance requirements for MDSAP certification.
• MDSAP Certification Decision: The audit organization makes the final decision regarding the issuance of the MDSAP certificate based on the audit report and corrective actions taken by the manufacturer.

8. Ensuring Global Compliance

• Cross-Jurisdictional Requirements: Since MDSAP is designed to meet the regulatory requirements of multiple countries (FDA in the U.S., Health Canada, ANVISA in Brazil, PMDA in Japan, and TGA in Australia), auditors ensure that the manufacturer’s QMS is compliant with all relevant regulations across these jurisdictions.
• Continuous Monitoring: Auditors also ensure that the manufacturer maintains compliance over time by participating in annual surveillance audits, ensuring ongoing compliance with MDSAP standards.

9. Maintaining Auditor Competence

• Continual Education: Auditors are required to maintain their knowledge and skills to keep up with the changing regulatory landscape and audit techniques. This includes attending training, participating in proficiency tests, and staying current with industry best practices.

Summary of Key Responsibilities:

1. Planning and scheduling the audit.
2. Reviewing documentation (pre-audit and during the audit).
3. Assessing compliance with ISO 13485, FDA regulations, and other MDSAP jurisdictions.
4. Conducting on-site inspections, including interviews and observations.
5. Identifying and documenting nonconformities.
6. Providing audit findings in a detailed report.
7. Following up on corrective actions and verifying their effectiveness.
8. Issuing the final MDSAP report and certification.
9. Ensuring global regulatory compliance for all MDSAP participating countries.

In summary, MDSAP auditors have a comprehensive set of responsibilities aimed at ensuring that manufacturers comply with international regulatory standards and maintain the highest levels of quality in their medical devices. Their work is critical to the certification process and to ensuring the safety and effectiveness of medical devices in the global market.

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