Orcanos

Orcanos is a fiercely specialized, highly technical, and massive powerhouse platform (originating from Israel) that built a massive reputation by solving a highly specific, terrifyingly complex problem: "Software as a Medical Device (SaMD)." While traditional QMS handles physical plastics and screws, Orcanos is explicitly engineered to handle complex software code that is classified as a medical device (like an AI diagnostic algorithm). The absolute core superpower of Orcanos is its "Unified ALM (Application Lifecycle Management) and QMS." When building an AI medical device, the software code *is* the product. Orcanos tracks the software requirements, the complex code testing, the bug tracking, and perfectly links all of that digital code data directly to the FDA ISO 14971 Risk Management file. Because it completely dominates the agonizing complexity of software-driven medical devices, offering unparalleled R&D code tracing and bulletproof FDA compliance, it is the inescapable standard for Digital Health startups and AI medical companies.