Merican Achieves ISO 13485 Certification, which is an international standard for medical devices and related products.
For 18 years, we have been committed to providing expert services in accordance with international standards.
Merican is pleased to announce that it has successfully achieved ISO 13485 certification, the internationally recognised quality management system standard for medical devices. This milestone is a testament to Merican’s unwavering commitment to product safety, quality excellence and global compliance, further solidifying the brand’s 18 years of industry expertise.
Please could you provide me with a definition of ISO 13485?
ISO 13485 is a globally recognised standard that specifies the requirements for a quality management system applicable to medical devices. It places stringent demands on product design and development, risk management, production control, traceability, documentation, and continuous improvement.
Achieving this certification is a testament to Merican’s ability to consistently deliver safe, reliable, and high-quality products that meet international regulatory and customer expectations.
The company has been recognised for its brand strength and reliability with multiple certifications over the past 18 years.
For 18 years, Merican has been dedicated to the health and light therapy equipment industry. This commitment has resulted in a strong reputation, built on innovation, reliability and customer-centric values. During its global expansion, Merican has consistently aligned its operations with international quality and safety standards, earning multiple authoritative certifications and validations in the process.
The successful attainment of ISO 13485 further strengthens Merican’s comprehensive quality framework, providing solid evidence of its mature R&D capabilities, standardised manufacturing processes, and rigorous quality control systems.
We are committed to ongoing investment in quality and manufacturing.
To ensure long-term product safety and performance, Merican continues to make substantial investments in:
- The company has state-of-the-art manufacturing facilities and automated production lines.
- The company has robust quality management and internal audit systems in place.
- Our company is proud to have professional R&D and quality assurance teams.
Ensuring end-to-end traceability and risk control throughout the product lifecycle is of paramount importance.
Every detail of Merican’s operations is designed with the customer in mind, ensuring consistent quality, reduced risk and reliable product performance.
Looking ahead: Improving standards to ensure excellence
Achieving ISO 13485 certification is not the end of the process, but the beginning of a new one. Moving forward, Merican will continue to uphold medical-grade quality standards, further enhance its quality management systems, and deliver products that offer greater reliability, safety, and peace of mind to customers worldwide.
For 18 years, we have concentrated on quality.
We are proud to hold multiple certifications, which we believe instil a sense of confidence in our services.
Merican is committed to setting higher benchmarks for excellence in the global wellness and medical equipment industry.
