MedTech
Medical Device SaaS
Medical-device companies live inside a maze of regulation and quality control. We set out to build software that made design controls and Quality Management Systems feel navigable instead of daunting.
Problem
Getting from concept to market means clearing FDA standards with a steep learning curve — and no single platform tied design controls to quality management.
Solution
We built a SaaS platform that linked product design controls to a robust QMS, simplifying FDA approval and the quality management that follows it.
Details
RoleSenior Manager, Product
IndustryMedical Tech, SaaS
ToolsFigma, Alteryx, Python
SkillsUX Design, Data Analysis, User Research
ActionsMarket Analysis, User Interviews, Roadmapping, Wireframing
Result
Grounded in dozens of user interviews, the result cut cognitive load, kept teams compliant, and measurably lifted productivity across manufacturing and QA.
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