Generate High-Quality Regulatory Submissions
The Adaptiv Risk platform simplifies risk management throughout the TPLC and can generate the regulatory submission products needed to satisfy eSTAR with a push of a button.
Cybersecurity Risk Management for Smart Medical Device Manufacturers
The Future of Total Product Lifecycle Risk Management for Digital Health Technologies.
Fulfill cybersecurity compliance and unleash medical device innovation with Adaptiv Risk
Finding it a challenge to navigate the changing cybersecurity requirements for digital health solutions published by the FDA and EU MDR? Adaptiv Risk can simplify FDA and EU MDR cybersecurity requirements across the total product lifecycle (TPLC) so Medical Device Manufacturers can focus on innovation, not paperwork.
Complete Visibility
Connected ecosystems and software supply chains can make it difficult to understand your true cyber risk. The Adaptiv Risk platform makes it easy to see and manage your risks to make your FDA eSTAR filing a breeze.
Increased Productivity
The Adaptiv Risk platform makes it easy to manage a project's cybersecurity requirements with familiar and efficient user workflows for risk management, software bill of material (SBOM) generation and management, threat modeling, architecture diagramming and vulnerability tracking.
Across the Product Lifecycle
Cybersecurity is not a point-in-time requirement. From concept to launch and eventually to retirement, the Adaptiv Risk platform provides a proactive cybersecurity approach that will start providing value at any point in the lifecycle.
Robust Workflows
The Adaptiv Risk platform contains robust risk management workflows designed to help identify, track and report on all project risk.
Industry Standards
The Adaptiv Risk platform leverages industry standards such as CycloneDX for SBOM support and ISO 14971 for risk management.
Build Around eSTAR
The latest FDA requirements to satisfy eSTAR are complex. The Adaptiv Risk platform was built to streamline the regulatory submission process and ongoing monitoring with confidence.