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The audit process for MDSAP (Medical Device Single Audit Program) registration in the United States involves several key steps. Here's an overview:

1. Pre-Audit Preparation:

   • Manufacturers must ensure their quality management system (QMS) complies with the relevant standards, including ISO 13485.
   • Prepare all necessary documentation and records for review, such as product specifications, risk management files, and post-market surveillance data.

2. Selection of Auditing Organization:

   • Manufacturers need to select an accredited auditing organization recognized by the MDSAP program. These organizations conduct the audit on behalf of the participating regulatory authorities, including the FDA.

3. Audit Notification:

   • Once the audit organization is selected, they will notify the manufacturer of the audit schedule. The manufacturer should confirm the dates and ensure that all relevant personnel and documents are available for the audit.

4. Audit Conduct:

   • The audit is typically performed on-site, where the auditing organization evaluates the manufacturer’s QMS, processes, and compliance with ISO 13485 and the regulations of participating countries (including the FDA’s 21 CFR Part 820 for the U.S.).
   • Auditors will review records, inspect processes, and interview personnel to assess compliance.

5. Audit Findings and Nonconformities:

   • If any nonconformities or issues are identified during the audit, the manufacturer will be required to provide corrective actions and a plan to address them. Nonconformities can be classified as minor, major, or critical, depending on their severity.

6. Audit Report:

   • After the audit, the auditing organization prepares a detailed audit report, which is submitted to both the manufacturer and the regulatory authorities. This report outlines any nonconformities, findings, and corrective actions taken.

7. Corrective Actions and Follow-Up:

   • Manufacturers must implement corrective actions to address the identified nonconformities. In some cases, a follow-up audit or verification may be required to ensure the corrective actions are effectively implemented.

8. MDSAP Certificate Issuance:

   • Upon successful completion of the audit and resolution of any nonconformities, the manufacturer is granted an MDSAP certificate. This certificate demonstrates compliance with the regulatory requirements of all MDSAP participating countries, including the U.S. FDA, Canada, Brazil, Japan, and Australia.

9. Ongoing Surveillance and Re-Audit:

   • Manufacturers must undergo annual surveillance audits as part of the MDSAP program to ensure continued compliance. A full re-audit is typically required every 3 years.

By following this process, manufacturers can streamline their regulatory compliance and reduce the need for multiple audits across different countries, as MDSAP registration covers several jurisdictions simultaneously.

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