The Challenge
A novel physical device needs more than a regulatory classification. The evidence requirements for a novel device can vary wildly based on products that have been on the market before it and regulator's tolerance for risk. This is why engagement with regulators early and often in the development process is so critical.
Nordstar needed one partner that could turn engineering progress into a review-ready regulatory program across the EU and US while its core team stayed focused on the device. That meant bringing the major questions to regulators early, then translating the answers into a working development roadmap and a risk-based verification and validation program.
Nordstar brought in Dovetail to lead that program end to end.
The Solution and Outcome
Dovetail embedded regulatory and quality leadership into Nordstar's development program. Rather than treat the roadmap, QMS, regulator meetings, and verification as separate projects, the teams connected them in one system where each decision supports the next. Because the product Nordstar was building had novel components compared to products on the market, this required vetting my regulatory authorities early on to help them i) how those components were similar to products already on the market and ii) understand the risk profile of the components within the context of the state of the art.
One roadmap across two regulatory systems
Dovetail turned Nordstar's device concept and development goals into a coordinated EU and US roadmap targeting Class II pathways in each market. The roadmap sequences the quality, design, evidence, and regulator-engagement work and gives both teams one clear view of priorities, ownership, and progress. It also ensured that the critical path for submission was always top of mind and clearly defined.
A quality system built around the device
Dovetail helped establish a working QMS foundation and the core design-control processes around Nordstar's development work. The teams are using the system to bring approvals, supplier controls, product requirements, risk and usability work, technical evidence, and V&V planning into one coordinated structure.
Quality is part of day-to-day product development, not a separate exercise at the end.
Early direction from the EU pathway
Dovetail prepared Nordstar for an EU pre-application dialogue and supported the team through the meeting. The discussion gave Nordstar an early line of sight into expectations for design controls, usability, and clinical evidence requirements so that an understanding on the depth and breadth of clinical data could be established early and resources could be managed to meet internal timelines.
Direct FDA feedback before the next development phase
Dovetail prepared and supported Nordstar through an FDA Pre-Submission meeting. Dovetail attended FDA in person, bringing the device to demo and discussing the proposed pathway and early evidence questions in one focused discussion. The feedback gave Nordstar a clearer basis for its testing program and led into an active second Pre-Submission workstream to crystalize the minute details of the testing requirements.
From strategy into verification and validation
The collaboration has moved beyond regulatory planning. Nordstar is bringing product requirements, supplier controls, technical evidence, and risk inputs together to build a device-specific V&V plan. Dovetail continues to guide the test strategy and strengthen traceability between each evidence stream and the regulatory roadmap.
The result is one coordinated program from strategy to evidence. Nordstar now has one coordinated EU and US program, a working QMS foundation, early feedback from both regulatory systems, and a clear bridge into V&V. Dovetail remains embedded as the team advances the device through its next development and regulatory milestones.
