Quality Management System
Our Quality Management System is certified to ISO 13485.
Quality, Compliance, and Regulatory
At OKKO Health, we take pride in our commitment to regulatory excellence. With a team of experts in global regulations, Quality management systems and Information security, health care professionals, patients and partners can feel confident in our promise to deliver safe, quality and effective products.
Global Regulatory Intelligence
We carry out Continuous Global Regulatory Intelligence activities to ensure readiness for compliance across all territories.
Compliant Documentation
We maintain a Design History File and documentation compliant to IEC 62304 and 62366 requirements.
Software as a Medical Device
We are compliant with IEC 82304 for Software as Medical Device development and product development.
UK CE-marked
Our system is UK CE-marked in line with the Medical Devices Directive 93/42/EEC. Transition to EU MDR as Class IIa in progress.
ISO 27001 certified
Our Information Security Management System is certified to ISO 27001.
Cyber Essentials Certified
We are Cyber Essentials and Cyber Essentials Plus certified.
DSP Toolkit
We are NHS DSP Toolkit certified and have experience working with NHS trusts.