--- title: "All MedTech Terms - Authoritative medical device terminology" description: "Browse, search, filter, and paginate every defined MedTech term across regulatory, cybersecurity, software, quality, and more." lang: en json-ld: --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About Glossary # All MedTech Terms 489 sourced definitions covering the regulatory, quality, software, and cybersecurity vocabulary of modern medical devices. AllRegulatoryQuality & RiskCybersecurityClinical & TrialsStandardsSoftware & AIManufacturingPost-MarketInvestment & FinanceMarket SegmentsReimbursementCommercializationIndustry Bodies Path Any learning path FDA Cybersecurity 101 (11) 510(k) Fundamentals (7) QMS Foundations (10) SaMD & AI/ML Devices (9) EU MDR Essentials (9) Post-Market Mastery (9) Clinical Trials & Evidence (18) IVDR Essentials (13) De Novo & Breakthrough Pathways (11) Reimbursement & Market Access (14) Risk & Usability Deep Dive (9) Standards Stack for Medical Devices (10) Manufacturing & Supply Chain (14) Founder & Investor Primer (16) Software Team Onboarding (12) AI/ML Devices Deep Dive (9) Acronyms onlyStatus Any freshness Fresh (≤6 mo) Recent (6-12 mo) Older (>12 mo) fuzzyexact Showing 1–24 of 489 PaginatedA–Z [ Reimbursement ### 340B Drug Pricing Program(340B) Federal program providing discounted drugs to safety-net providers. ](/terms/340b)[ Investment & Finance ### 409A Valuation An independent fair-market-value appraisal of common stock used to set tax-compliant strike prices for employee stock options. ](/terms/409a-valuation)[ Post-Market ### 5-Day Report Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm. ](/terms/five-day-report)[ Regulatory ### 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory ### 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory ### 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Industry Bodies ### AAMI(AAMI) Standards body for medical instrumentation; co-publisher of ISO/IEC adoptions. ](/terms/aami)[ Cybersecurity ### AAMI SW96 aka Standard for medical device security AAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle. ](/terms/aami-sw96)[ Software & AI ### AAMI TIR45(TIR45) aka AAMI TIR45:2012/(R)2018 · Guidance on the use of AGILE practices in the development of medical device software AAMI Technical Information Report providing guidance on applying Agile software development practices within an IEC 62304-compliant medical device software lifecycle. ](/terms/aami-tir45)[ Cybersecurity ### AAMI TIR57 aka Principles for Medical Device Security - Risk Management AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management. ](/terms/aami-tir57)[ Cybersecurity ### AAMI TIR97(TIR97) aka AAMI TIR97:2019 · Post-market security risk management for device manufacturers AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57. ](/terms/aami-tir97)[ Regulatory ### Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k)[ Regulatory ### Accreditation Scheme for Conformity Assessment(ASCA) FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny. ](/terms/asca)[ Clinical & Trials ### Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial)[ Regulatory ### Additional Condition for Nonprescription Use(ACNU) FDA's 2024 final rule creating a pathway for nonprescription drug products that rely on additional conditions (e.g., self-selection tools, drug-device combinations) to ensure safe use without a healthcare provider. ](/terms/acnu)[ Industry Bodies ### AdvaMed U.S. trade association for the medical device and diagnostics industry. ](/terms/advamed)[ Commercialization ### AdvaMed Code of Ethics Industry code governing interactions between U.S. medical-device companies and healthcare professionals. ](/terms/advamed-code)[ Industry Bodies ### AdvaMedDx Diagnostics-focused division of AdvaMed. ](/terms/advameddx)[ Software & AI ### Adversarial Robustness Resilience of an ML model to inputs deliberately crafted to cause misclassification. ](/terms/adversarial-robustness)[ Clinical & Trials ### Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event)[ Commercialization ### Advisory Board Convening of external experts to advise on strategy or product. ](/terms/advisory-board)[ Market Segments ### Aesthetic & Energy-Based Devices aka Medical aesthetics · Energy-based devices · EBDs Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions. ](/terms/aesthetics-energy-devices)[ Regulatory ### AI Act Conformity Assessment (Medical Devices) For AI-enabled medical devices, AI Act requirements are assessed through the MDR/IVDR notified-body procedure, not a separate CE route. ](/terms/ai-act-conformity-assessment)[ Regulatory ### AI Act Post-Market Monitoring Ongoing, documented monitoring of a high-risk AI system's performance after it is placed on the market. ](/terms/ai-act-post-market-monitoring) Prev12… 21Next MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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