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.

Quality Management System

Our Quality Management System is certified to ISO 13485.

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.

For more details, copies of certifications or any questions please contact our Quality, Regulatory, and Compliance team.