We ensure that our algorithm is always informed on the newest regulatory changes.

All chatbot outputs are human reviewed by regulatory professionals to ensure accuracy.

We are lowering costs for medical device, SiMD, and SaMD companies, driving innovation and commercial success.

Our software meticulously analyzes your company information to provide strategy and guidance for FDA Pre-Market Approvals and 510Ks.

Our software create references to predicate devices to help you streamline your submission process.
Our software critically assess your application to ensure thorough preparation for FDA meetings and generates pre-meeting questions.

Formalized reports for first-step submissions and question preparation.

Guidance on device classification and intended uses.

Real-time regulatory policy updates are integrated into our algorithm to ensure you are always compliant.

Activate the AI consultant when you want to prepare for any FDA meeting, whether a standard submission or an audit.

We offer customizable payment plans to ensure we are accessible to startups.
Get the benefits of a traditional human consultant with a model trained with FDA consultants.
Model is trained on large corpus of data ensuring objectivity and accuracy in the regulatory process.
Catalyzing growth and innovation with unparalleled speed, a seamless user experience.