MedTech Terms
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    456 sourced terms · updated continuously

    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.

    456
    Defined terms
    13
    Categories
    1361
    Source citations
    16
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    Eight categories. One vocabulary.

    All categories
    67 terms
    Regulatory
    FDA, EU MDR/IVDR, and global pathways for getting devices to market.
    36 terms
    Quality & Risk
    QMS, risk management, and process controls for medical devices.
    60 terms
    Cybersecurity
    Threat modeling, SBOMs, and secure-by-design for connected devices.
    48 terms
    Clinical & Trials
    Clinical evidence, investigations, and human-factors studies.
    22 terms
    Standards
    ISO, IEC, AAMI, and other consensus standards used by regulators.
    31 terms
    Software & AI
    SaMD, SiMD, AI/ML models, and software lifecycle terminology.
    22 terms
    Manufacturing
    Design transfer, production controls, and supply chain terms.
    22 terms
    Post-Market
    Surveillance, vigilance, recalls, and lifecycle management.
    38 terms
    Investment & Finance
    Venture financing, term sheets, valuation, and capital structure for MedTech startups.
    38 terms
    Market Segments
    Therapeutic and technology segments - cardiovascular, IVD, surgical robotics, DTx, and more.
    36 terms
    Reimbursement
    Coding, coverage, and payment pathways across CMS, commercial payers, and global HTAs.
    23 terms
    Commercialization
    Go-to-market, sales channels, KOLs, and hospital purchasing dynamics.
    13 terms
    Industry Bodies
    Vendor-neutral trade associations, standards-setting organizations, professional societies, public-private consortia, and non-commercial accelerator programs.
    Most referenced

    Start with these essentials

    All terms
    Regulatory

    510(k) Premarket Notification(510(k))

    FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
    Regulatory

    Premarket Approval(PMA)

    FDA's most stringent device marketing application, required for high-risk Class III devices.
    Regulatory

    De Novo Classification Request(De Novo)

    Pathway to classify novel low- to moderate-risk devices that lack a predicate.
    Quality & Risk

    Quality System Regulation(QSR / 21 CFR 820)

    FDA's current good manufacturing practice (cGMP) requirements for medical devices.
    Quality & Risk

    Quality Management System Regulation(QMSR)

    FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
    Standards

    ISO 13485

    International standard for medical device quality management systems.

    Updated daily

    Latest in MedTech

    Fresh FDA 510(k) clearances and PubMed publications, auto-linked to glossary terms.

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    Recent FDA 510(k) clearances

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