Learning paths
Hand-picked reading orders to build fluency in a subdomain of MedTech terminology, one term at a time. Progress is saved on this device. Sign in to sync across devices.
FDA Cybersecurity 101
The premarket cybersecurity vocabulary every MedTech engineer and RA professional now needs.
510(k) Fundamentals
From predicate selection to substantial equivalence to RTA - the core 510(k) toolkit.
QMS Foundations
Quality system terminology grounded in QSR, the upcoming QMSR, and ISO 13485.
SaMD & AI/ML Devices
From SaMD basics to PCCPs and Good Machine Learning Practice for AI-enabled devices.
EU MDR Essentials
The European regulatory vocabulary for placing devices on the EU market.
Post-Market Mastery
Surveillance, vigilance, recalls, and the feedback loop into risk and design.
Clinical Trials & Evidence
The vocabulary of medical device clinical investigation, from IDE and IRB through endpoints, GCP, and real-world evidence.
IVDR Essentials
Placing in vitro diagnostics on the EU market: classification, Notified Body scope, performance evaluation, and post-market performance follow-up.
De Novo & Breakthrough Pathways
Novel and expedited FDA pathways for devices with no predicate or that address unmet needs, plus Q-Submission and Pre-Submission mechanics.
Reimbursement & Market Access
Coverage, coding, and payment fundamentals: CPT, HCPCS, ICD-10, CMS coverage decisions, TCET, prior authorization, and health economics.
Risk & Usability Deep Dive
ISO 14971 risk management paired with IEC 62366-1 usability engineering, the two lifecycle standards regulators expect on every device.
Standards Stack for Medical Devices
The map of ISO and IEC standards that apply to a typical medical device, from QMS through electrical safety, software, biocompatibility, and usability.
Manufacturing & Supply Chain
Process validation, sterilization, cleanroom controls, supplier management, and lifecycle traceability for finished-device manufacturing.
Founder & Investor Primer
The regulatory, market, and financing vocabulary a MedTech founder or investor needs to evaluate a device opportunity.
Software Team Onboarding
What software engineers joining a MedTech team need to know: IEC 62304 lifecycle, SOUP, cybersecurity under Section 524B, and AI change control.
AI/ML Devices Deep Dive
For teams shipping AI-enabled devices: PCCP mechanics, GMLP, model documentation, drift monitoring, and generative-AI considerations.