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
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
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
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
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