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GMP Manufacturing Services

We are establishing a GMP (Good Manufacturing Practice) system for medical devices that meets international standards, ensuring safety and reliability throughout the entire process from product design to production and quality control.

  • Tailored for Implantable and Wearable Bioelectronic Devices Incorporating aseptic manufacturing environments, material traceability, and long-term safety evaluation procedures to address the unique characteristics of implantable and wearable medical devices.
  • Compliant Quality Management Implementing a quality management system aligned with ISO 13485 and domestic and global regulatory requirements to ensure that innovative technologies developed in R&D can be reliably translated into clinical and commercial applications.
  • GMP-Based Manufacturing Infrastructure Building a robust GMP-compliant manufacturing infrastructure to support safe, high-quality production from research through commercialization.