Future-proof your AI, Streamline your validation.

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)

,adherence to Good Machine Learning Practices (GMLP)

, and alignment with the latest U.S. Government Executive Order on AI .

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.

Navigating regulatory pathways for medical AI, including PCCP and GMLP compliance

Regulatory Landscape Assessment

Gap Analysis

Strategy Development

Implementation of Compliance Measures

Validation Study Design & Planning

Validation Execution

Documentation and Reporting

Regulatory Submission

Communication & Collaboration with FDA

Adaptation to Changes

Validation - As - A - Service

Submit your model to Gesund.ai platform

Securely upload your medical AI models to initiate the validation journey with Gesund.ai.

Facilitate data curation and integration

Collaborate with Gesund.ai to curate and integrate high-quality data from our trusted partners, tailored for your model's validation.

Collaborate with expert readers during data annotation

Work alongside Gesund.ai's expert annotators, providing guidelines to ensure data is annotated accurately for your model's specific needs. Skip this stage if your data is already annotated.

Generate and review model predictions

Observe and evaluate the predictions generated by your AI model when fed with the annotated data, pivotal for the validation process.

Analyze validation metrics and model performance

Examine the calculated validation metrics visually, comparing your model's outputs against ground truth annotations, to understand its performance.

Access dashboard for analysis and export results

Utilize the comprehensive dashboard to filter, analyze, and conduct essential evaluations like bias and fairness. Export your findings in various formats for thorough examination.

Validate your model against case-specific, real-world data for free!

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