The Challenge
For clinical AI intended to inform time-critical care like sepsis, market access and regulatory authorization is far from a paperwork exercise. Every product decision—from its clinical claims to how clinicians interact with it and how it evolves with future features—can shape its classification, evidence requirements, and route to market.
STRIVE also needed to navigate two regulatory systems at once. The FDA and EU MDR pathways share some similar foundations, but are fundamentally different in the way they evaluate the same device. STRIVE needed one coherent development and evidence program, with a market-specific strategy for each jurisdiction.
That required more than periodic advice. It required an accountable regulatory team that could understand the device deeply, make the strategic calls, engage regulators early, and lead the entire journey through execution.
How Dovetail Helped
Built one program for two regulatory systems. Dovetail created a shared regulatory core, then tailored the claims, pathway, and sequence for each market. STRIVE kept one coherent product strategy while each jurisdiction received the regulatory approach it required.
Put the decisive questions in front of regulators early. Dovetail prepared and guided STRIVE through an FDA Pre-Submission and all structured dialogues with a notified body. Early engagement turned regulatory judgment into concrete direction before major execution choices were locked in.
Made regulatory strategy operational. Dovetail implemented STRIVE's QMS and led the team through its internal audit, management review, and study execution. Clinical, engineering, quality, and regulatory decisions now move through one coordinated program.
Stayed accountable through execution. Dovetail's experts and platform keep decisions, evidence, owners, and dependencies connected as the program advances through verification and validation and toward submission. Feedback from regulators was implemented at the right stages so no time was lost.
The Solution and Outcome
STRIVE moved smoothly from its first regulatory roadmap through notified-body structured dialogues and a completed FDA Pre-Submission meeting.
Dovetail turned that strategy into a working dual-market program. The QMS was implemented, the internal audit and management review were completed, the usability study was completed, and subsequent notified-body discussions ensured each stage was planned and vetted.
Dovetail continues to lead STRIVE's journey toward US and EU market access this year.
