Gesund.ai offers comprehensive solutions to future-proof your AI and streamline validation processes.
We address the evolving landscape of regulatory requirements, including compliance with the Predetermined Change Control Plan (PCCP)
Our expertise ensures that your medical AI solutions not only meet but exceed the standards for safety, effectiveness, and equity, facilitating successful market entry.
It’s comprising a partner network of readers and hospitals, regulatory expertise as well as proprietary Machine Learning Operations (MLOps) platform, amplifies pivotal studies minimizing uncertainty while maximizing speed and predictability for regulatory clearance. We believe our customers are best suited focusing on their core technologies while we scale clinical validation and evidence for ultimate clinical impact.