The Challenge
Chromacare is developing an at-home ferritin self-test designed to make biomarker monitoring more convenient outside traditional laboratory settings.
Advancing an intuitive at-home product through a high-stakes regulatory process calls for more than a pathway recommendation. Product positioning, evidence planning, quality processes, regulator feedback and assessment readiness all need to reinforce one another as the device evolves. This is all in addition to standing up manufacturing and assembly procedures from scratch.
Chromacare works with Dovetail as an end-to-end regulatory and quality partner, creating one connected route from product decisions to regulator and assessor expectations while the team continues to build.
The Solution and Outcome
Dovetail structured the collaboration around four linked milestones: a coordinated program connecting strategy, quality, evidence and external feedback.
An executable, staged regulatory roadmap
Dovetail translated a complex, multi-market regulatory landscape into a sequenced plan linking product positioning, pathway and predicate strategy, testing expectations, quality readiness and future product capabilities. The roadmap has evolved alongside the device and now supports a staged approach targeting Class II pathways.
A quality foundation built for execution
Chromacare and Dovetail established a structured QMS foundation spanning controlled quality processes, design controls, training and assessment readiness. By integrating quality work with product and manufacturing decisions, the collaboration gives Chromacare a practical operating framework for the next phase of development.
Direct FDA feedback, converted into action
Dovetail prepared for and represented Chromacare in a completed FDA Pre-Submission interaction. The approach required a sophisticated approach utilizing predicate devices to support Chromacare's unique device characteristics. The team translated feedback into a staged action plan, implementing FDAs feedback to near-term actions as well as formulating strategy for subsequent pre-submissions.
MDSAP Audit Preparation
Dovetail ensured that Chromacare was properly setup, documented, and trained for their MDSAP audits, as will be required for their Health Canada submission, including establishment of various manufacturing and assembly procedures. This process connected quality-system maturity, team training, production controls and internal readiness activities to a clear assessment plan.
Since at least 2025, Chromacare and Dovetail have turned regulatory ambition into a coordinated program: an executing roadmap, a structured QMS foundation, direct FDA feedback and rolling evidence generation.
Chromacare are now preparing for their submissions to both FDA and Health Canada.
