The Platform · Cobra

A methodology, with a platform attached.

Cobra is not a tool that automates your work. It is a methodology for clinical evaluation under EU MDR — strategic conversations first, structured platform work next, human judgement throughout — with a platform that scales the methodology while keeping regulatory authority where it belongs.

Tendai

Your guide

Closer to working with a capable colleague than to operating a tool.

• Strategic conversations come first. Before any platform work begins, we sit with the device team and define the regulatory architecture of the project. Indications, predicate landscape, transfer technologies, methodological tensions. The output is alignment — and alignment is what makes the rest defensible.
• The platform structures, the human decides. Search plans, classification proposals, evidence mapping. Each step produces structured output — but every classification, every override, every annotation is captured with the reviewer's signature. AI proposes. Regulatory authority stays human.
• Reproducibility is the real value, not speed. A parameterised search plan can be re-run a year from now and produce the same baseline plus the new evidence that has appeared since. The methodology persists across time, across reviewers, across audit cycles.
• Meaning, written per study. For the studies that carry argumentative weight, reviewer notes capture methodological function, limitations, and concrete framing for the CER author. The output is not a list. It is a working document the author uses while writing.