SGS has awarded Yaoshi the world’s first IECEE CB certification under IEC 81001-5-1:2021 for its ultra-widefield scanning laser ophthalmoscope, or SLO, following a detailed assessment and conformity review.
Yaoshi, a developer of advanced ophthalmic imaging technology, reached this milestone with its Yetsea 300 series. Along with the cybersecurity certification, SGS also issued CB certifications for electrical safety and electromagnetic compatibility, reflecting a broad compliance review that covered safety, performance and cybersecurity together.
IEC 81001-5-1 is an international standard focused on cybersecurity across the full lifecycle of health software and IT systems, from development and testing to post-market monitoring and response. As the first certification of its kind within the IECEE CB Scheme, this marks a new benchmark for cybersecurity in medical devices.
To evaluate Yaoshi’s compliance, SGS carried out a structured assessment that included threat modeling, risk assessment, penetration testing, vulnerability scanning, code auditing and a review of the software bill of materials. These steps were used to identify possible risks at the product level.
SGS also examined cybersecurity management processes and supporting documentation at the system level, checking how security practices were built into quality management, development, testing and post-market activities. Through this independent review, the company verified alignment with international cybersecurity, safety and performance requirements.
As cybersecurity becomes a core part of regulatory compliance, medical device makers are under growing pressure to show strong, lifecycle-based security practices. The IECEE CB Scheme helps support international acceptance of test results, which can reduce duplicate testing and speed up access to major markets such as Europe, North America and Japan.
SGS said it continues to expand its global cybersecurity certification capabilities to support medical device manufacturers as requirements evolve. Through its worldwide network of medical device experts, the company aims to provide testing, auditing and certification services in one place.
SGS DIGITAL TRUST is the company’s broader framework for helping organizations navigate the digital trust landscape with a more structured approach. It brings together SGS’ expertise across technologies, services and industries to help customers build, demonstrate and maintain trust across the digital ecosystem.
Leadership Comment
Gavin Yin, Director of Medical Devices Services, East China, Connectivity & Products at SGS, said the certification represents an important step in addressing cybersecurity risks in connected medical devices. He added that SGS combines expertise in cybersecurity, electrical safety and EMC to help manufacturers keep pace with changing regulatory expectations and strengthen trust in healthcare technology.
