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The MDSAP audit for medical device registration under the United States FDA system evaluates the manufacturer’s compliance with the ISO 13485 standard and FDA’s Quality System Regulations (QSR), along with other requirements specific to the participating countries. Below are the main audit contents for MDSAP:

1. Management Responsibility

• Evaluation of top management’s commitment to the quality management system (QMS), including policy, planning, objectives, and review of quality management processes.
• Ensuring there is a system in place for assigning responsibilities and ensuring accountability for compliance.

2. Quality Management System (QMS)

• Review of the overall quality management system, including its structure, documentation, and the effectiveness of its implementation.
• Examination of how the manufacturer manages the QMS across its entire organization and in compliance with both ISO 13485 and FDA regulations.

3. Resource Management

• Assessing the adequacy of resources to maintain the QMS, including human resources, infrastructure, and training.
• Review of personnel qualifications, training records, and the capability of the production and testing facilities.

4. Design and Development Controls

• Evaluation of the design and development processes, including how the manufacturer controls the design phase, manages risks, and ensures that the final product meets specifications and user needs.
• Examination of design input, design reviews, design verification and validation, and design changes.

5. Production and Process Controls

• Audit of manufacturing processes to ensure they are carried out in accordance with established procedures, including process validation and control.
• Review of the device master record (DMR) and device history record (DHR), ensuring the product is consistently made to the correct specifications.

6. Post-Market Surveillance and Corrective Actions

• Review of systems in place for monitoring the performance of the device once it is on the market. This includes tracking adverse events, complaints, product recalls, and field actions.
• Evaluation of the Corrective and Preventive Action (CAPA) system to address any non-conformities, customer complaints, or product issues.

7. Risk Management

• Evaluation of the manufacturer's approach to risk management throughout the product lifecycle. This includes identifying, evaluating, and mitigating risks associated with the device.
• Review of how risk management is integrated into design, production, and post-market activities.

8. Supplier and Purchasing Controls

• Assessing the management of suppliers and subcontractors, ensuring they meet specified quality standards. This includes supplier qualification, supplier monitoring, and the handling of purchased materials.
• Evaluation of purchase order controls and verification of supplier quality.

9. Non-Conformity and Complaint Handling

• Review of processes for managing product non-conformities and customer complaints.
• Ensuring that complaints are investigated, corrective actions are implemented, and any necessary regulatory reporting is done (e.g., FDA's Medical Device Reporting (MDR) system).

10. Labeling and Documentation Control

• Evaluation of labeling practices to ensure that all product labels and instructions for use comply with regulatory requirements (such as 21 CFR Part 801 for the U.S.).
• Ensuring proper control over all QMS documents and records, including document approval, version control, and storage.

11. Internal Audits

• Assessing the effectiveness of the manufacturer’s internal audit program to ensure continuous improvement.
• Review of internal audit results, corrective actions taken, and follow-up on any previous audit findings.

12. Regulatory Reporting and Compliance

• Evaluation of the manufacturer’s compliance with regulatory requirements, including FDA's Medical Device Reporting (MDR) system, adverse event reporting, and device recalls.
• Ensuring the manufacturer’s ability to meet post-market surveillance obligations and regulatory obligations in all jurisdictions covered by the MDSAP.

Summary

In summary, the MDSAP audit for medical device registration under the FDA system covers a wide range of areas related to quality management, manufacturing processes, regulatory compliance, and post-market surveillance. It assesses the manufacturer’s adherence to ISO 13485 and FDA’s QSR, ensuring that the device is safe, effective, and consistently produced according to regulatory standards.

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