Client Case Study
Prototyping
Design
Development
Flow Medical is creating the new standard of care for interventional pulmonary embolism treatment.
What we delivered:
- Market / Product Requirements Specifications (Design Inputs)
- Risk Management Plan
- Preliminary Usability Evaluation
- Use Specification
- Use FMEA
- Preliminary Hazard Analysis
- Software Requirements Specification
- Software Development SOP
- Preclinical Testing Support
- Prototype design & benchtop testing
- Labeling Requirements Specification
- Regulatory Strategy
- Design and Development Plan
- Intellectual Property development
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