MedTech Terms
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    Pick any two terms to see definitions, context, pitfalls, and sources in parallel.

    Curated comparison tables

    In-depth, attribute-by-attribute tables for the most common MedTech term pairs. Each row is sourced from the linked term pages.

    Comparison table

    510(k) vs PMA

    FDA clearance vs FDA approval: the two main US premarket pathways

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    Comparison table

    SaMD vs SiMD

    Software as a Medical Device vs Software in a Medical Device

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    Comparison table

    ISO 13485 vs 21 CFR 820 (QSR / QMSR)

    International QMS standard vs the US FDA quality system regulation

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    Comparison table

    IEC 62304 vs ISO 14971

    Software lifecycle standard vs medical device risk management standard

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    Comparison table

    EU MDR vs EU IVDR

    Regulation (EU) 2017/745 vs Regulation (EU) 2017/746

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    Cybersecurity

    LINDDUN

    In one line
    Privacy threat modeling framework that decomposes privacy threats into seven categories, the privacy counterpart to STRIDE.
    Definition
    LINDDUN is a privacy threat-modeling methodology developed at KU Leuven. Current threat types are Linking, Identifying, Non-repudiation, Detecting, Data disclosure, Unawareness and unintervenability, and Non-compliance. GO supports lightweight workshops; PRO supports systematic analysis. Record privacy threats and select appropriate treatments.
    Why it matters
    LINDDUN can complement security threat modeling for identifiable health data. GDPR Article 25 addresses data protection by design and default; HIPAA imposes applicable privacy and security duties but does not specifically mandate a LINDDUN or GDPR-style privacy-by-design analysis.
    Common pitfalls
    • •Running STRIDE only and assuming privacy is covered, STRIDE addresses security; LINDDUN addresses privacy, and they identify different threats.
    • •Skipping the PET (privacy-enhancing technology) mapping, without it, LINDDUN produces threats with no controls.
    • •Limiting LINDDUN to the data layer, privacy threats also arise from UI design (Unawareness) and process design (Non-compliance).
    Sources
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    Why compare MedTech terms side by side?

    MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

    Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

    Common comparison patterns

    How to use this tool

    Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

    MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.