SGS issues first IEC 81001-5-1 CB cybersecurity certification for a medical device

SGS awarded Yaoshi what it described as the world’s first IECEE CB certification under IEC 81001-5-1:2021 for a medical device, covering the company’s Yetsea 300 series ultra-widefield scanning laser ophthalmoscope. The milestone signals tighter cybersecurity expectations for connected medical devices and may help speed acceptance in major markets.

Why it matters: - The certification sets a new benchmark for cybersecurity in medical devices under the IECEE CB Scheme. - IEC 81001-5-1 covers cybersecurity across the full life cycle of health software and IT systems, from design and development to testing and post-market activities. - The IECEE CB Scheme supports international acceptance of test results, which can reduce duplicated testing and help manufacturers move faster into markets such as Europe, North America and Japan. - Cybersecurity has become a core part of regulatory compliance for connected medical devices.

What happened: - SGS awarded Yaoshi the world’s first IECEE CB certification in accordance with IEC 81001-5-1:2021 for its ultra-widefield scanning laser ophthalmoscope. - The certification covers Yaoshi’s Yetsea 300 series. - SGS said the award followed a comprehensive assessment and conformity verification process. - SGS also issued CB certifications for electrical safety and electromagnetic compatibility, or EMC.

The details: - SGS evaluated Yaoshi’s compliance with IEC 81001-5-1 requirements through a structured assessment program. - Product-level review included threat modeling, risk assessment, penetration testing, vulnerability scanning, code auditing and software bill of materials, or SBOM, review. - System-level review covered cybersecurity management processes and supporting documentation. - SGS verified the integration of security practices across quality management, development, testing and post-market monitoring and response activities. - The assessment confirmed alignment with international cybersecurity, safety and performance requirements. - Gavin Yin, director of Medical Devices Services, East China, Connectivity & Products at SGS, said the certification marks a significant step in addressing cybersecurity risks in connected medical devices. - Gavin Yin said SGS combines cybersecurity, electrical safety and EMC expertise to help manufacturers meet evolving regulatory expectations and strengthen trust in healthcare technologies.

Between the lines: - The certification points to a broader shift in medical device regulation, where cybersecurity is treated alongside safety and performance rather than as a separate add-on. - SGS is positioning its testing and certification services as a one-stop offering for manufacturers facing more complex global requirements. - SGS DIGITAL TRUST frames the company’s broader push to consolidate digital trust services across technologies, services and organizations.

What's next: - SGS said it will continue expanding global cybersecurity certification capabilities for medical device manufacturers. - The company also said it will keep supporting one-stop services covering product testing, auditing and certification. - Broader use of IEC 81001-5-1 within the IECEE CB Scheme could further shape how connected medical devices are evaluated for international markets.

The bottom line: - Yaoshi’s certification is a first-mover milestone for medical device cybersecurity and a signal that global compliance now requires lifecycle-based security evidence, not just traditional safety testing.