Panda Surgical achieves ISO 13485 certification
Panda Surgical achieved ISO 13485:2016 certification for its medical-device quality management system.
Evidence notes
- The certification covers the company's processes for medical-device safety, reliability and regulatory compliance.
- Panda is preparing a handheld robotic platform for minimally invasive neurosurgery.
- The quality system supports the company's planned clinical investigation and regulatory work.
Company context
Panda Surgical develops handheld dexterous robotics for minimally invasive neurosurgery. The UCL spinout combines wristed exchangeable instruments with AI-assisted software to give neurosurgeons greater control when operating through narrow corridors in the brain and spine.