Panda Surgical achieves ISO 13485 certification
London, UK — May 07, 2026 — Panda Surgical proudly announces that it has officially achieved ISO 13485:2016 certification, the internationally recognised quality management standard for the medical device industry.
ISO 13485:2016 is a comprehensive framework specifically designed for the medical device industry to ensure every product is safe, effective, and consistent. It places a heavy emphasis on risk management, evaluation, and traceability. For a company to be certified, it must undergo a rigorous audit of its entire lifecycle, proving that every step is documented, controlled, and optimized for patient safety.
Achieving this certification validates Panda Surgical’s commitment to developing breakthrough robotic systems for endoscopic neurosurgery under the most stringent regulatory requirements. Because the margin for error in neurosurgery is exceptionally thin, maintaining a rigorous quality system provides surgeons and patients with confidence that the Panda Surgical technology is developed, tested, and refined against the highest industry standards.
‘This achievement is a testament to the meticulous standards of our entire engineering team. Going through this certification process ensured that our uncompromising commitment to safety, reliability, and traceability is embedded in every single component we design’ said liana Fragkioudaki, Panda Surgical Quality Engineer, who led the certification effort.
Manios Dimitrakakis, Panda Surgical CEO, added "Achieving this certification is a major milestone for us, as it aligns our design and development processes with the highest global standards. It reinforces our commitment to making patient safety the utmost priority in everything we build."
About Panda Surgical
Panda Surgical, a University College London spinout, is developing the world’s first dexterous robot for minimally invasive neurosurgery, offering surgeons enhanced dexterity and decision-support making these complex operations safer, more effective, and more widely adopted.
For further information, please contact: contact@panda-surgical.com
