メリカン社がISOを達成 13485 認証

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メリカン社がISOを達成 13485 認証

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18 Years of Proven Expertise Backed by International Standards

Merican is proud to announce that it has successfully achieved ISO 13485 certification, the internationally recognized quality management system standard for medical devices. This milestone marks a significant step forward in Merican’s commitment to product safety, quality excellence, and global compliance, while further reinforcing the brand’s 18 years of industry expertise.

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What Is ISO 13485?

ISO 13485 is a globally accepted standard that defines the requirements for a quality management system specific to medical devices. It places stringent demands on product design and development, risk management, production control, traceability, documentation, and continuous improvement.
Achieving this certification demonstrates Merican’s ability to consistently deliver 安全, reliable, and high-quality products that meet international regulatory and customer expectations.

18 Years of Brand Strength, Proven by Multiple Certifications

18 years of dedication to the health and light therapy equipment industry, Merican has built a strong reputation based on innovation, 信頼性, and customer-centric values. Throughout its global expansion, Merican has continuously aligned its operations with international quality and safety standards, earning multiple authoritative certifications and validations along the way.

The successful attainment of ISO 13485 further strengthens Merican’s comprehensive quality framework, providing solid evidence of its mature R&D capabilities, standardized manufacturing processes, and rigorous quality control systems.

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Continuous Investment in Quality and Manufacturing

To ensure long-term product safety and performance, Merican continues to make substantial investments in:

  • Advanced manufacturing facilities and automated production lines
  • Robust quality management and internal audit systems
  • Professional R&D and quality assurance teams
  • End-to-end traceability and risk control throughout the product lifecycle

Every detail of Merican’s operations is designed with the customer in mind, ensuring consistent quality, reduced risk, and dependable product performance.

Looking Ahead: Raising the Bar for Quality

The achievement of ISO 13485 certification is not an endpoint, but a new beginning. Moving forward, Merican will continue to uphold medical-grade quality standards, further enhance its quality management systems, and deliver products that offer greater reliability, 安全性, and peace of mind to customers worldwide.

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18 years of focus on quality.
Multiple certifications that inspire trust.

Merican remains committed to setting higher benchmarks for excellence in the global wellness and medical equipment industry.

正式版本 (红光疗床)13485体系证书中文版2025 2028 00

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