Fillow
Fillow Disc is an innovative new menstrual product that combines the ease of use of tampons with the reusability of menstrual cups
What we delivered:
Risk Analysis
Preliminary Hazard Analysis
Quality Plan
Regulatory Strategy
Contract manufacturer engagement & sourcing
device prototyping & technical de-risking
Design for Manufacturability
ISO 13485 compliant Quality Management System (QMS)
Phase reviews