FDA, European Union and Health Canada Regulatory/QMS Checklist
Self-Assess Your Current Regulatory Commercialization
Inventory and Analyse Your Medical Device Efforts
Compare your answers with stages of StarFish Medical’s Proven Product Development Process to understand your ability to meet applicable regulatory requirements.
Determine and Interpret Your Results for:
Intended Use
Target Markets
Device Risk Class & Product Code
Regulatory Pathway
Quality Management System
Consensus standards
Essential Performance
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