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2026-02-04

The second stage of the ISO audit was successfully completed

From January 30 to February 1, 2026, Hunan MPLETN Optoelectronics Technology Co., Ltd. successfully underwent the second-stage on-site audit of the ISO 13485 Medical Device Quality Management System conducted by two senior auditors from Shanghai SNQA Certification Co., Ltd.

During the three-day audit, the audit team conducted a comprehensive, detailed, and rigorous review of various departments including management, quality, production, research and development, and sales, based on the requirements of the ISO13485:2016 standard, relevant laws and regulations, and the company's system documents. The audit was carried out through on-site observations, interviews, and examination of records. Staff from all departments actively cooperated and responded carefully, demonstrating the company's profound understanding and effective implementation of its quality management system.

At the final review meeting, the audit instructor gave a positive evaluation of the company's quality management system in terms of compliance, effectiveness, and continuous improvement, marking the successful completion of this on-site audit. The passing of this audit is an important step for the companys quality management to advance to a new stage, laying a solid foundation for further strengthening product market competitiveness and enhancing customer trust. Hunan MPLENT Optoelectronics Technology Co., Ltd. will continue to optimize the system's operation to ensure the suitability, adequacy, and effectiveness of quality management.

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