A complete walkthrough of the FDA’s 510(k) eSTAR template—covering every major module,
from device description and predicates to testing, labeling, cybersecurity, and final submission structure.
9 Videos
A practical guide to building a successful De Novo submission,
including evidence strategy, benefit–risk analysis, classification logic,
and documentation requirements for novel medical devices.
8 Videos
A concise overview of the FDA’s 351/HCT/P framework, including classification criteria,
approval expectations, and compliance essentials for human cell and tissue products.
1 Video
A clear introduction to SaMD compliance—covering documentation, cybersecurity,
validation, risk integration, and quality system alignment. Includes a free SaMD template.
1 Video
A practical introduction to Failure Modes and Effects Analysis,
demonstrating how to identify risks, score severity, apply mitigations,
and integrate FMEA into FDA design controls.
2 Videos