Myopia goggles does not need medical equipment approved in Taiwan, but Eradiate does concern more and more participating in swimming population. Many of them spend NT$5,000 to NT$10,000 for a pair of eyeglasses, same as they should buy a good quality of swimming goggles for better and much clear version.
Eradiate keeps on the road, by upgrading swimming goggles quality to ISO 13485 medical equipment level. This ensures every single pair of Sable swimming goggles can be traced and recorded in every process. Delivery the best quality and reliable goggles to consumers with no doubt!
2014- Sable received both ISO13485 and ISO 9001 certifications done by SGS Lab.
ISO13485 is to facilitate harmonized medical device regulatory requirements for quality management systems.
Sable brand presented by Eradiate Enterprise Co. Ltd., is considering to:
- Focus on design transfer and management activities during product development.
- Specific requirements for traceability and inspection for devices that are implantable.
- Specific requirements for validation and documentation for the processes of sterile medical devices.
-Specific requirements for verification of the effectiveness of corrective and preventive actions.
Meanwhile, ISO 9001 specifies requirements for a quality management system where Eradiate
- needs to demonstrate
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ility to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
- aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
Both international standards ISO13485 and ISO9001 help us to take a fully quality control, from design, developing, purchasing, and manufacturing. We do believe that customer satisfaction drives us move forward.