Learn
Learning paths
Hand-picked reading orders to build fluency in a subdomain of MedTech terminology, one term at a time.
Engineers · RA · QA11 terms
FDA Cybersecurity 101
The premarket cybersecurity vocabulary every MedTech engineer and RA professional now needs.
524BPremarket Cybersecurity SubmissionSPDFThreat ModelingSTRIDESBOM+5 more
Start path
RA · Product7 terms
510(k) Fundamentals
From predicate selection to substantial equivalence to RTA - the core 510(k) toolkit.
510(k)Predicate DeviceSEIntended UseIFU (statement)RTA+1 more
Start path
QA · Operations10 terms
QMS Foundations
Quality system terminology grounded in QSR, the upcoming QMSR, and ISO 13485.
QSR / 21 CFR 820QMSRISO 13485Design ControlsV&VDHF+4 more
Start path
Software · Data · RA9 terms
SaMD & AI/ML Devices
From SaMD basics to PCCPs and Good Machine Learning Practice for AI-enabled devices.
SaMDSiMDIEC 62304Software Safety ClassificationSOUPCDS+3 more
Start path
RA · International9 terms
EU MDR Essentials
The European regulatory vocabulary for placing devices on the EU market.
MDRIVDRCE MarkNBEUDAMEDUDI+3 more
Start path
PMS · QA · RA9 terms
Post-Market Mastery
Surveillance, vigilance, recalls, and the feedback loop into risk and design.
PMSPSURMedical Device VigilanceFSCAMedical Device RecallMDR+3 more
Start path