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Product Quality Control

Supplying high quality products under strict quality control systems that meet global standards.

A high level of safety is demanded for pharmaceuticals and medical devices. To ensure that we are providing the highest quality products, we have an effective quality management system that fully meets Japanese and foreign regulatory requirements.

We are ISO 13485 certified with regard to the "development, production, and distribution of hyaluronic acid based viscoelastic products for medical use." We strictly control the quality of products from the product design and development stage all the way through to post-sales service in accordance with systems and standards for manufacturing management and quality assurance.

Products are made through a process that involves rigorous quality testing, such as receiving inspection of raw materials, tests conducted during production, and inspection of all finished products.

ISO 13485

The International Organization for Standardization (ISO) is an international standard-setting body comprising representatives from various national standards organizations. ISO 13485, one of the international standards established by the ISO, specifies requirements for the design and development, production, etc. of medical devices and has been adopted in many companies all over the world. ISO 13485 has been prepared based on the ISO 9001, and includes requirements that are specifically related to medical device safety and efficacy.


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