Risk Management

How Does Adaptiv Risk Handle Risks?

While Adaptiv Risk is heavily focused on cybersecurity, there is no reason that it cannot be used for all types of device risk. From customizations to review workflows to audit logging, Adaptiv Risk provides all the tools needed to easily manage risks beyond just cybersecurity. In fact, hazard analysis in Adaptiv Risk is based on ISO 14971 and with DFMEA, fault trees and use-related risk support available, all of the pieces are there for total risk management.

• Standards: Adaptiv Risk leverages ISO 14971 for hazard analysis along with DFMEA, fault tree and use-related risk support.
• Customizable: Adaptiv Risk provides multiple customization options to make the risk workflows adapt to your company's requirements.
• Traceability: All roads lead back to risks when it comes to medical devices and Adaptiv Risk makes it easy to trace threats and vulnerabilities to device risks.

The FDA expects robust risk management and Adaptiv Risk makes satisfying the numerous risk management requirements, both cyber and non-cyber, in eSTAR a breeze.