--- title: "MedTech Terms: Medical Device & Cybersecurity Glossary" description: "Plain-language, sourced definitions across regulatory, quality, clinical, reimbursement, cybersecurity, software/AI, standards, manufacturing, post-market,..." lang: en json-ld: | { "@context": "https://schema.org", "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com", "description": "The authoritative reference for medical device terminology.", "potentialAction": { "@type": "SearchAction", "target": { "@type": "EntryPoint", "urlTemplate": "https://medtechterms.com/terms?q={query}" }, "query-input": "required name=query" } } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About ![](/hero-medtech.jpg) 489 sourced terms · updated daily # The authoritative reference for MedTech terminology . Clear, sourced definitions for every regulatory, quality, cybersecurity, and software term that shapes modern medical devices. Each term has its own page, with citations and links to primary sources. [Browse all](/terms) [Browse all terms](/terms)[A–Z index](/a-z) 489 Defined terms 13 Categories 1460 Source citations 16 Learning paths Beyond the dictionary ## Tools to learn the language faster [ ### Learning paths Curated reading orders for FDA cyber, 510(k), QMS, SaMD/AI, EU MDR, and post-market. Open ](/paths)[ ### Compare terms Put two terms side-by-side. Great for 510(k) vs PMA, SaMD vs SiMD, QSR vs ISO 13485. Open ](/compare)[ ### Acronym quiz Test yourself on the MedTech acronyms that show up in every meeting and submission. Open ](/quiz) Browse ## 13 categories. One vocabulary. [All categories](/categories) [ 99 terms Regulatory FDA, EU MDR/IVDR, and global pathways for getting devices to market. ](/categories#regulatory)[ 36 terms Quality & Risk QMS, risk management, and process controls for medical devices. ](/categories#quality---risk)[ 60 terms Cybersecurity Threat modeling, SBOMs, and secure-by-design for connected devices. ](/categories#cybersecurity)[ 49 terms Clinical & Trials Clinical evidence, investigations, and human-factors studies. ](/categories#clinical---trials)[ 22 terms Standards ISO, IEC, AAMI, and other consensus standards used by regulators. ](/categories#standards)[ 31 terms Software & AI SaMD, SiMD, AI/ML models, and software lifecycle terminology. ](/categories#software---ai)[ 22 terms Manufacturing Design transfer, production controls, and supply chain terms. ](/categories#manufacturing)[ 22 terms Post-Market Surveillance, vigilance, recalls, and lifecycle management. ](/categories#post-market)[ 38 terms Investment & Finance Venture financing, term sheets, valuation, and capital structure for MedTech startups. ](/categories#investment---finance)[ 38 terms Market Segments Therapeutic and technology segments - cardiovascular, IVD, surgical robotics, DTx, and more. ](/categories#market-segments)[ 36 terms Reimbursement Coding, coverage, and payment pathways across CMS, commercial payers, and global HTAs. ](/categories#reimbursement)[ 23 terms Commercialization Go-to-market, sales channels, KOLs, and hospital purchasing dynamics. ](/categories#commercialization)[ 13 terms Industry Bodies Vendor-neutral trade associations, standards-setting organizations, professional societies, public-private consortia, and non-commercial accelerator programs. ](/categories#industry-bodies) Most referenced ## Start with these essentials [All terms](/terms) [ Regulatory ### 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory ### Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma)[ Regulatory ### De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. ](/terms/de-novo)[ Quality & Risk ### Quality System Regulation(QSR / 21 CFR 820) FDA's current good manufacturing practice (cGMP) requirements for medical devices. ](/terms/qsr)[ Quality & Risk ### Quality Management System Regulation(QMSR) FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference. ](/terms/qmsr)[ Standards ### ISO 13485 International standard for medical device quality management systems. ](/terms/iso-13485) Updated daily ## Latest in MedTech Fresh FDA 510(k) clearances, PMA approvals, recalls, clinical trials, and PubMed publications, auto-linked to glossary terms. [View all](/latest) ### Recent FDA 510(k) clearances [View all](/latest) - [Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260754) Assure Tech., LLC · 2026-06-05 [pen test](/terms/pen-test) - [Catalyze ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253204) BioTissue Holdings, Inc. · 2026-06-05 - [Perfect-O Ostial Positioning Catheter ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260289) Balosmark, Inc. · 2026-06-05 - [Digital C-ARM with 3D ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253296) Allengers Medical Systems Limited · 2026-06-05 - [VEOFIX Snap Off Screw ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253108) Steps Ortho · 2026-06-05 ### Recent FDA recalls [View all](/latest) - [DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm) ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2305-2026) Class II · DeRoyal Industries Inc · 2026-05-18 - [Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2240-2026) Class II · Medtronic Neuromodulation · 2026-05-13 [neuromodulation](/terms/neuromodulation) - [Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2241-2026) Class II · Medtronic Neuromodulation · 2026-05-13 [neuromodulation](/terms/neuromodulation) - [Atlan A350XL. Model Number: 8621600. anesthesia workstation ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2208-2026) Class I · Draeger, Inc. · 2026-05-07 - [Atlan A350. Model Number: 8211500. anesthesia workstation ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2207-2026) Class I · Draeger, Inc. · 2026-05-07 ### Recent FDA warning letters [View all](/latest) No entries yet. ### Recent PubMed publications [View all](/latest) - [Reproducibility of accelerated fatigue test of dentin-composite discs under cyclic diametral compression. ](https://pubmed.ncbi.nlm.nih.gov/41862357/) Dental materials : official publication of the Academy of Dental Materials · 2026-08-01 - [The intelligent ear: AI and hearing aids information seeking and users' discussion on social media. ](https://pubmed.ncbi.nlm.nih.gov/42190300/) Patient education and counseling · 2026-08-01 - [Co-assembly of zwitterionic and cationic polymers for antibacterial and antithrombotic surfaces via weak electrostatic interactions. ](https://pubmed.ncbi.nlm.nih.gov/41795405/) Biomaterials · 2026-08-01 - [An open-source microphysiological system for the evaluation of cardiovascular materials and devices under controlled flow conditions. ](https://pubmed.ncbi.nlm.nih.gov/41924823/) Biomaterials advances · 2026-08-01 - [The small interfering RNA imdusiran as single and multiple doses in healthy, randomised individuals and non-randomised individuals with chronic hepatitis B (AB-729-001): a phase 1a/b trial. ](https://pubmed.ncbi.nlm.nih.gov/42173110/) The lancet. Gastroenterology & hepatology · 2026-07-01 Companion resources ## More from the Blue Goat network Sister sites and references that go deeper on specific topics covered in this glossary. [ Related site ### MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com)[ Related site ### MedTech Cyber Tips Practical, organized tips for medical device cybersecurity teams. ](https://medtechcybertips.com)[ Related site ### MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com)[ Related site ### AI SaMD Insights How AI is changing SaMD - risk, regulation, and good machine-learning practice. ](https://ai-samd.com)[ Related site ### Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com)[ Related site ### MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) Sponsor Independently edited. Sponsored by Blue Goat Cyber. Medical device cybersecurity - premarket submissions, SBOMs, threat modeling, and penetration testing. [Visit Blue Goat Cyber](https://bluegoatcyber.com) 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)