Information Security and Medical Device Registration

As a responsible medical software manufacturer, we're committed to ensuring that our AI software is safe and effective. We're deeply invested in healthcare information security.

Lunit and Global Medical Device Regulations

Lunit processes the following particulars of personal information:

1. 1. Registration
2. 1. - Lunit INSIGHT is ready to use more than 56 countries with CE mark, FDA clearance and MFDS approval.
   2. - Lunit SCOPE PD-L1 has received CE mark
3. 2. Certification
4. 1. - Manufacturing site
      • ISO13485:2016 Quality management systems
      • MDSAP (Medical Device Single Audit Program)
      • Korea GMP (Good Manufacturing Practice)
   2. - Company
      • ISO27001 Information security management
        ISO/IEC 27001 is a global information security standard requiring that an organization systematically examine information security risks, design and implement a coherent and comprehensive suite of information security controls and adopt a process to meet these needs on an ongoing basis. Lunit.io is ISO 27001 certified.