Risk Management Process Overview

ZenZen follows a structured risk management process based on internationally recognised standards, including ISO 14971 for medical device risk management and IEC 62304 for software lifecycle safety. We systematically identify, assess, and control potential risks across our product, infrastructure, and operations. Each identified risk receives documented evaluation, mitigation measures, and ongoing monitoring.

Our team performs continuous reviews and updates to ensure that new features, data flows, and clinical insights are assessed before release. Protective measures, safeguards, and monitoring processes are built directly into the design of the ZenZen system to maintain a high level of safety for all users.