Client Case Study
Design
Development
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
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