Quality

Quality Management System

Soyama Co., Ltd. has established and maintains a Quality Management System in compliance with ISO 13485:2016, applicable to medical device manufacturing and assembly activities.

In 2025, the company successfully obtained ISO 13485 certification, demonstrating our commitment to consistent quality, regulatory compliance, and controlled manufacturing processes.

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Medical Device Manufacturing & Assembly

We have extensive experience in the assembly of medical devices, with all related production activities conducted under defined and controlled conditions. Manufacturing processes are designed to ensure product safety, reliability, and repeatability.

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Cleanroom Manufacturing

Medical device products are manufactured and assembled in cleanroom environments, where contamination risks are strictly controlled. Environmental conditions are monitored to maintain stable and consistent product quality in accordance with medical industry requirements.

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Quality Commitment

Soyama Co., Ltd. is committed to:

• Compliance with applicable regulatory and customer requirements

• Stable and repeatable manufacturing processes

• Continuous improvement of quality systems

• Long-term and reliable partnership with customers

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