--- title: "Learning Paths - MedTech Terms" description: "Curated reading orders to learn MedTech subdomains: FDA cybersecurity, 510(k), QMS, SaMD/AI, EU MDR, and post-market." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "BreadcrumbList", "@id": "https://medtechterms.com/paths#breadcrumb", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Learning paths", "item": "https://medtechterms.com/paths" } ] }, { "@type": "ItemList", "@id": "https://medtechterms.com/paths#paths", "name": "MedTech learning paths", "description": "Curated reading orders to learn MedTech subdomains, one term at a time.", "itemListOrder": "https://schema.org/ItemListOrderAscending", "numberOfItems": 16, "itemListElement": [ { "@type": "ListItem", "position": 1, "url": "https://medtechterms.com/paths/fda-cybersecurity-101", "item": { "@type": "Course", "@id": 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"https://medtechterms.com/paths/qms-foundations#course", "name": "QMS Foundations", "description": "Quality system terminology grounded in QSR, the upcoming QMSR, and ISO 13485.", "url": "https://medtechterms.com/paths/qms-foundations", "provider": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" } } }, { "@type": "ListItem", "position": 4, "url": "https://medtechterms.com/paths/samd-and-ai", "item": { "@type": "Course", "@id": "https://medtechterms.com/paths/samd-and-ai#course", "name": "SaMD & AI/ML Devices", "description": "From SaMD basics to PCCPs and Good Machine Learning Practice for AI-enabled devices.", "url": "https://medtechterms.com/paths/samd-and-ai", "provider": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" } } }, { "@type": "ListItem", "position": 5, "url": "https://medtechterms.com/paths/eu-mdr-essentials", "item": { "@type": "Course", "@id": 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"https://medtechterms.com/paths/clinical-trials-and-evidence#course", "name": "Clinical Trials & Evidence", "description": "The vocabulary of medical device clinical investigation, from IDE and IRB through endpoints, GCP, and real-world evidence.", "url": "https://medtechterms.com/paths/clinical-trials-and-evidence", "provider": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" } } }, { "@type": "ListItem", "position": 8, "url": "https://medtechterms.com/paths/ivdr-essentials", "item": { "@type": "Course", "@id": "https://medtechterms.com/paths/ivdr-essentials#course", "name": "IVDR Essentials", "description": "Placing in vitro diagnostics on the EU market: classification, Notified Body scope, performance evaluation, and post-market performance follow-up.", "url": "https://medtechterms.com/paths/ivdr-essentials", "provider": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" } } }, { "@type": "ListItem", "position": 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"https://medtechterms.com" } } }, { "@type": "ListItem", "position": 16, "url": "https://medtechterms.com/paths/ai-ml-devices-deep-dive", "item": { "@type": "Course", "@id": "https://medtechterms.com/paths/ai-ml-devices-deep-dive#course", "name": "AI/ML Devices Deep Dive", "description": "For teams shipping AI-enabled devices: PCCP mechanics, GMLP, model documentation, drift monitoring, and generative-AI considerations.", "url": "https://medtechterms.com/paths/ai-ml-devices-deep-dive", "provider": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" } } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About Learn # 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.](/account) [ Engineers · RA · QA 11 terms ## FDA Cybersecurity 101 The premarket cybersecurity vocabulary every MedTech engineer and RA professional now needs. 524B Premarket Cybersecurity Submission SPDF Threat Modeling STRIDE SBOM +5 more Start path ](/paths/fda-cybersecurity-101)[ RA · Product 7 terms ## 510(k) Fundamentals From predicate selection to substantial equivalence to RTA - the core 510(k) toolkit. 510(k) Predicate Device SE Intended Use IFU (statement) RTA +1 more Start path ](/paths/510k-fundamentals)[ QA · Operations 10 terms ## QMS Foundations Quality system terminology grounded in QSR, the upcoming QMSR, and ISO 13485. QSR / 21 CFR 820 QMSR ISO 13485 Design Controls V&V DHF +4 more Start path ](/paths/qms-foundations)[ Software · Data · RA 9 terms ## SaMD & AI/ML Devices From SaMD basics to PCCPs and Good Machine Learning Practice for AI-enabled devices. SaMD SiMD IEC 62304 Software Safety Classification SOUP CDS +3 more Start path ](/paths/samd-and-ai)[ RA · International 9 terms ## EU MDR Essentials The European regulatory vocabulary for placing devices on the EU market. MDR IVDR CE Mark NB EUDAMED UDI +3 more Start path ](/paths/eu-mdr-essentials)[ PMS · QA · RA 9 terms ## Post-Market Mastery Surveillance, vigilance, recalls, and the feedback loop into risk and design. PMS PSUR Medical Device Vigilance FSCA Medical Device Recall MDR +3 more Start path ](/paths/post-market-mastery)[ Clinical · RA · Biostats 18 terms ## Clinical Trials & Evidence The vocabulary of medical device clinical investigation, from IDE and IRB through endpoints, GCP, and real-world evidence. IDE IDE Supplement IDE Annual Progress Report IRB Informed Consent GCP +12 more Start path ](/paths/clinical-trials-and-evidence)[ IVD RA · Clinical · QA 13 terms ## IVDR Essentials Placing in vitro diagnostics on the EU market: classification, Notified Body scope, performance evaluation, and post-market performance follow-up. IVDR IVDR Risk Classes A–D CDx CE Mark NB GSPRs +7 more Start path ](/paths/ivdr-essentials)[ RA · Startup · Product 11 terms ## 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. De Novo BDD Q-Sub Q-Sub / Pre-Sub Intended Use IFU (statement) +5 more Start path ](/paths/de-novo-and-breakthrough)[ Market Access · Commercial · RA 14 terms ## Reimbursement & Market Access Coverage, coding, and payment fundamentals: CPT, HCPCS, ICD-10, CMS coverage decisions, TCET, prior authorization, and health economics. CPT CPT HCPCS ICD-10-CM / ICD-10-PCS NCD / LCD LCD and NCD +8 more Start path ](/paths/reimbursement-and-market-access)[ R&D · Human Factors · QA 9 terms ## Risk & Usability Deep Dive ISO 14971 risk management paired with IEC 62366-1 usability engineering, the two lifecycle standards regulators expect on every device. ISO 14971 RMF Risk Acceptability Matrix IEC 62366-1 HFE Use Specification +3 more Start path ](/paths/risk-and-usability)[ R&D · QA · RA 10 terms ## 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. ISO 13485 ISO 14971 IEC 60601-1 IEC 60601-1-2 IEC 62304 IEC 62366-1 +4 more Start path ](/paths/standards-stack)[ Operations · QA · Supply Chain 14 terms ## Manufacturing & Supply Chain Process validation, sterilization, cleanroom controls, supplier management, and lifecycle traceability for finished-device manufacturing. Process Validation IQ / OQ / PQ Sterilization ISO 11135 Cleanroom Classes (ISO 14644) Biocompatibility +8 more Start path ](/paths/manufacturing-and-supply-chain)[ Founders · Investors · BD 16 terms ## Founder & Investor Primer The regulatory, market, and financing vocabulary a MedTech founder or investor needs to evaluate a device opportunity. TAM / SAM / SOM 510(k) PMA De Novo BDD FTO +10 more Start path ](/paths/founder-and-investor-primer)[ Software · DevOps · Security 12 terms ## 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. SaMD SiMD IEC 62304 Software Safety Classification SOUP V&V +6 more Start path ](/paths/software-team-onboarding)[ Data · ML · RA 9 terms ## AI/ML Devices Deep Dive For teams shipping AI-enabled devices: PCCP mechanics, GMLP, model documentation, drift monitoring, and generative-AI considerations. AI/ML-Enabled Medical Device PCCP GMLP Model Card Model Drift Monitoring Explainability and Interpretability +3 more Start path ](/paths/ai-ml-devices-deep-dive) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)