Free Medical Device Regulatory Checklist

Ready for Medical Device Regulatory?

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
   Regulatory Checklist

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