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Learning paths

Pick the path that fits.

Five curated tracks through the open library. Each one is a sequence of chapters that walks you from where you are to a working understanding — using the same articles, just in a deliberate order.

Founder Track

From device idea to documented FDA strategy

  • 1Is your product even a medical device?
  • 2What class is it — I, II, or III?
  • 3Which pathway: 510(k), De Novo, or PMA?
  • 4What it costs and how long it takes
  • +2 more
6 chapters9 articles~72 min

RA Lead Track

Standardize how your team writes 510(k)s, risk files, and design history files

  • 1Your eSTAR section playbook
  • 2Hazard libraries that scale (ISO 14971)
  • 3Design controls under 21 CFR 820.30
  • 4Pre-Sub requests, done right
  • +2 more
6 chapters9 articles~72 min

SaMD & AI Track

For software and AI/ML medical device teams navigating CDRH's evolving guidance

  • 1Is your software a medical device?
  • 2IMDRF risk categorization
  • 3IEC 62304 software lifecycle
  • 4PCCPs for AI-enabled devices
  • +2 more
6 chapters10 articles~80 min

International Track

Enter the US market from abroad. The whole pathway, in plain English.

  • 1Why FDA clearance matters globally
  • 2US vs EU - how the pathways differ
  • 3Can you reuse CE Mark clinical data?
  • 4US Agent and FDA registration
  • +2 more
6 chapters11 articles~88 min

Post-Market Track

Your device is on the market. Stay compliant. Survive inspections. Avoid recalls.

  • 1Post-market surveillance, end to end
  • 2Adverse event reporting (MDR)
  • 3Inspections and Form 483
  • 4Warning letters - prevent, decode, respond
  • +2 more
6 chapters12 articles~96 min