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:
- Lunit INSIGHT is ready to use more than 56 countries with CE
mark, FDA clearance and MFDS approval.
- Lunit SCOPE PD-L1 has received CE mark
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