MedTech Terms
    The authoritative reference
    416 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.

    416
    Defined terms
    13
    Categories
    1258
    Source citations
    6
    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

    Compare terms

    Put two terms side-by-side. Great for 510(k) vs PMA, SaMD vs SiMD, QSR vs ISO 13485.

    Open

    Acronym quiz

    Test yourself on the MedTech acronyms that show up in every meeting and submission.

    Open
    Browse

    Eight categories. One vocabulary.

    All categories
    59 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.
    42 terms
    Cybersecurity
    Threat modeling, SBOMs, and secure-by-design for connected devices.
    41 terms
    Clinical & Trials
    Clinical evidence, investigations, and human-factors studies.
    21 terms
    Standards
    ISO, IEC, AAMI, and other consensus standards used by regulators.
    26 terms
    Software & AI
    SaMD, SiMD, AI/ML models, and software lifecycle terminology.
    22 terms
    Manufacturing
    Design transfer, production controls, and supply chain terms.
    21 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.
    Quality & Risk

    Quality System Regulation(QSR / 21 CFR 820)

    FDA's current good manufacturing practice (cGMP) requirements for medical devices.
    Standards

    ISO 13485

    International standard for medical device quality management systems.
    Standards

    ISO 14971

    International standard for the application of risk management to medical devices.
    Standards

    IEC 62304

    Lifecycle requirements for medical device software.

    Updated weekly

    Latest in MedTech

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

    View all

    Recent FDA 510(k) clearances

    View all

    Recent FDA recalls

    View all

    Recent FDA warning letters

    View all

    No entries yet.

    Recent PubMed publications

    View all

    Recent Clinical trials

    View all
    Companion resources

    More from the Blue Goat network

    Sister sites and references that go deeper on specific topics covered in this glossary.

    Sponsor
    Independently edited. Sponsored by Blue Goat Cyber.

    Medical device cybersecurity - premarket submissions, SBOMs, threat modeling, and penetration testing.

    Visit Blue Goat Cyber