WALK101 Obtains 'ISO 13485' International Medical Device QMS Certification
Verified that WALK101's medical device development and quality management processes meet international standards through ISO 13485 certification, strengthening global regulatory response capabilities.
Hello, this is the WALK101 Newsletter.
In this issue, we share the news that WALK101 has obtained ISO 13485 certification, the international standard for medical device quality management systems (QMS). This certification is not just a 'documentary requirement', but an important step to officially prove that the entire process of medical device development and operation is managed under consistent quality standards.
What does ISO 13485 mean?
ISO 13485 is an international standard to stably guarantee quality throughout the entire process of an organization designing, developing, producing, and maintaining medical devices. Particularly in the Software as a Medical Device (SaMD) field, the core of trust lies in how robustly the quality system—such as change management, verification, documentation, and traceability—is operated, rather than a declaration that 'development was done well'.
- ► Standardization of development process: Managing consistently from requirements → design → implementation → testing → launch
- ► Strengthening change management and history management: Maintaining quality tailored to the characteristics of SaMD where updates and improvements repeat
- ► Securing verifiable evidence: Establishing a basis for 'explainable quality' such as test records, traceability, and risk management
The 'Prepared Stage' going toward global regulations (FDA/CE)
ISO 13485 certification is a core foundation for expanding into the global market. Regulatory requirements vary by country, but they all primarily look at 'how reliable the quality system is'. Through this certification, WALK101 has strengthened the quality operation capabilities required in the global healthcare market and paved the ground to gradually pursue regulatory approval strategies (FDA/CE, etc.) in the future.
WALK101's Direction
WALK101 is expanding its product lineups including GMSM, an AI-based X-ray image analysis software, and Scandia, a body surface analysis app. As products increase, 'consistency of quality' becomes more important. Under the ISO 13485 system, WALK101 will continue to strengthen process-oriented operations so that each product can be validated and maintained with the same standards.