The audit process for MDSAP (Medical Device Single Audit Program) registration for medical devices in the United States involves several steps, focused on assessing the manufacturer's Quality Management System (QMS) for compliance with the regulatory requirements of the U.S. FDA, as well as other participating countries (Canada, Brazil, Japan, and Australia). Below is an outline of the typical audit process:

1. Pre-Audit Preparation

• Selection of an Auditing Organization: The manufacturer must select an MDSAP-recognized auditing organization, which is authorized to perform audits on behalf of the regulatory authorities.
• Pre-Audit Documentation: The manufacturer provides necessary documentation to the auditing organization, including a copy of their ISO 13485 certification (if available), QMS documentation, product lists, and any other required records related to the manufacturing and regulatory compliance processes.
• Audit Planning: The manufacturer and auditing organization agree on the audit scope, schedule, and any additional requirements. The auditing organization may request information about the manufacturer’s facility, products, and processes.

2. Opening Meeting

• Introduction and Overview: The audit begins with an opening meeting, where the auditing team introduces themselves and explains the audit objectives and process.
• Review of Audit Scope: The scope of the audit is reviewed to ensure both parties are aligned on the areas to be audited, including the manufacturer's QMS, production processes, and specific medical devices.
• Audit Plan Confirmation: The auditing organization confirms the audit schedule and addresses any questions or concerns from the manufacturer.

3. Document Review

• QMS and Regulatory Documentation: The auditors review the manufacturer’s QMS documentation, including:
  • ISO 13485 documentation (if applicable)
  • FDA 21 CFR Part 820 compliance documents (for U.S. market)
  • Design and development records
  • Supplier and subcontractor management processes
  • Risk management processes
  • Post-market surveillance and complaint handling records
• Pre-Audit Questionnaire Review: Any pre-audit questionnaires or checklists submitted by the manufacturer are reviewed to ensure that the manufacturer has provided the necessary information.

4. On-Site Audit

• Facility Inspection: The auditing team conducts an on-site inspection of the manufacturer's facility. This includes reviewing production areas, quality control processes, and equipment.
• Interviews with Personnel: Auditors conduct interviews with key personnel involved in various aspects of the QMS, including quality managers, production staff, regulatory affairs staff, and management.
• Process Observations: Auditors observe manufacturing processes, including document control, risk management, and production to ensure that procedures are being followed in accordance with the QMS and regulatory requirements.
• Verification of Compliance: The auditors assess compliance with regulations for all jurisdictions covered by MDSAP (FDA, Health Canada, ANVISA, PMDA, TGA) by checking the company’s practices against regulatory requirements for medical devices in those regions.

5. Nonconformity Identification

• Documentation of Nonconformities: If any nonconformities (NCs) or potential issues are found during the audit, auditors document these in detail. Nonconformities may be classified as minor, major, or critical, depending on their impact on patient safety and regulatory compliance.
• Root Cause Analysis: The auditors may request a root cause analysis from the manufacturer if the nonconformity is significant. This is to understand whether the issue is isolated or systemic.

6. Audit Report Preparation

• Findings and Recommendations: After the on-site audit, the auditors prepare a report summarizing their findings, including any nonconformities identified, and provide recommendations for corrective actions.
• Corrective Action Plan: The manufacturer must develop and submit a corrective action plan for addressing any nonconformities identified during the audit. The auditors review and verify the adequacy of this plan.

7. Closing Meeting

• Summary of Findings: The audit concludes with a closing meeting, where the auditors provide an overview of their findings, including any nonconformities and potential risks.
• Audit Report Discussion: The auditors discuss the report and provide feedback on any corrective actions required. They may also offer guidance on how to address issues and improve compliance.
• Certification Decision: Based on the audit report and corrective actions, the auditing organization decides whether the manufacturer meets the requirements for MDSAP certification.

8. Follow-Up and Corrective Actions

• Implementation of Corrective Actions: If nonconformities are found, the manufacturer must implement corrective actions and provide evidence of these actions to the auditing organization.
• Follow-Up Audit (if necessary): In cases of critical or major nonconformities, a follow-up audit may be conducted to verify that corrective actions have been properly implemented.

9. Issuance of MDSAP Certificate

• Final Report and Certification: Once the manufacturer has addressed all nonconformities and provided evidence of corrective actions, the auditing organization issues the final MDSAP report. If the manufacturer meets all requirements, they are awarded the MDSAP certificate.
• Ongoing Surveillance: MDSAP certification is not permanent; manufacturers must undergo annual surveillance audits to ensure ongoing compliance with the relevant regulations.

10. Surveillance Audits (Annual)

• Annual Review: The manufacturer must undergo annual surveillance audits to maintain their MDSAP certification. These audits help ensure that the manufacturer continues to comply with the regulatory standards and QMS requirements of MDSAP participating countries.

Summary of the MDSAP Audit Process:

1. Pre-audit preparation: Select auditing organization, provide documentation.
2. Opening meeting: Discuss audit objectives and scope.
3. Document review: Assess QMS and regulatory compliance.
4. On-site audit: Inspect facilities, processes, and interview staff.
5. Identify nonconformities: Document findings and request corrective actions.
6. Audit report: Summarize findings, recommend corrective actions.
7. Closing meeting: Discuss findings and corrective action plans.
8. Follow-up: Ensure corrective actions are taken.
9. Certification decision: Award MDSAP certification if compliant.
10. Surveillance: Annual audits to maintain certification.

By following these steps, the MDSAP audit process helps ensure that medical device manufacturers meet the regulatory requirements for multiple countries through a single, unified audit.

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