FDA regulatory support for medical device software.

That depends on its intended use, users, outputs and the consequences of relying on those outputs. We assess the product against the device definition and relevant exclusions, then document the reasoning and likely classification rather than relying on a feature checklist.

A Pre-Sub is most valuable when FDA feedback could change an expensive decision: the predicate strategy, clinical study, performance endpoints, cybersecurity approach, AI/ML change protocol or the proposed regulatory pathway. It should contain focused questions and enough background for FDA to answer them.

A 510(k) generally demonstrates substantial equivalence to a legally marketed predicate. De Novo is available for certain novel low-to-moderate-risk devices without a suitable predicate and establishes a new classification regulation and special controls. The right route depends on the intended use, technology and predicate landscape.

Yes. We can work with your internal team or another lead consultant and own defined sections such as software documentation, cybersecurity, risk management, V&V, AI/ML evidence or technical responses. Roles, interfaces and review responsibility are agreed at the start.

FDA controls the regulatory decision, so no consultant can promise an unconditional outcome. We can commit to defined deliverables, review standards and timelines within our control after assessing the product, evidence and pathway.

Yes. We can support the technical and regulatory submission work for non-US manufacturers. Separate US Agent, establishment registration, device listing and importer requirements may apply depending on the commercial arrangement and stage of market entry.