Hypervision Surgical has attained certification to ISO/IEC 27001:2022 and ISO/IEC 27701:2019, the international standards for information security management and privacy information management. Awarded following an independent audit, the certifications extend the company’s compliance framework beyond the medical device itself to the data that makes it intelligent.
ISO/IEC 27001 sets out the requirements for systematically identifying, managing and reducing information security risk. ISO/IEC 27701 extends it with specific controls for the processing of personal data, mapped to GDPR and comparable privacy regimes. For a company whose HYPERSNAP® Surgical System combines hyperspectral imaging with AI-powered analytics, the two standards govern the foundation the technology rests on: intraoperative image data informs every model developed and every insight returned to the surgeon, and the integrity of that data pipeline is inseparable from the safety of the system built on it.
When we achieved ISO 13485 certification, we committed to building quality management into everything we do. ISO 27001 and ISO 27701 apply that same discipline to information security and privacy. For our hospital partners, it means the data entrusted to us is governed with the same rigour as the devices we put in their operating theatres.
— Jaco Jacobs, Chief Operations Officer of Hypervision Surgical
The certifications build on Hypervision Surgical’s UKCA marking and FDA 510(k) clearance for the HYPERSNAP® Surgical System.