About DDF Flow

DDF Flow is an FDA regulatory intelligence platform that helps medical device companies move from a product idea to a complete, submission-ready documentation set in a fraction of the time traditional methods require. It starts with an AI classification engine that determines your device class, regulatory pathway (510(k), De Novo, PMA, or Exempt), software safety class, and the applicable regulations and consensus standards. From there it automatically assembles a full document tree of 90+ design-control and submission documents — from user needs and design inputs through risk management, software documentation, V&V protocols, design transfer, and labeling — and drafts each one with AI pre-filled content tailored to your device profile.

It is built for regulatory leads, quality engineers, and founders at medical device startups and scale-ups who are preparing their first or next FDA submission and need to produce consistent, traceable, audit-ready documentation without a large regulatory team. Predicate search, FMEA and risk tools, a live traceability matrix, and a central facts registry keep every document aligned and change-controlled as your design evolves.

DDF Flow is built by Illobra, a small team of regulatory and software engineers focused on making regulatory compliance faster, clearer, and more accessible for medical device innovators.