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

    Open comparison
    Cybersecurity

    NIST CSWP 35, Cybersecurity Threat Modeling the Genomic Data Sequencing Workflow(NIST CSWP 35)

    In one line
    NIST initial public draft illustrating cybersecurity threat modeling for a genomic data sequencing and analysis workflow.
    Definition
    NIST CSWP 35 initial public draft, Cybersecurity Threat Modeling the Genomic Data Sequencing Workflow: An example threat model implementation for genomic data sequencing and analysis, was published December 16, 2024. It illustrates threat modeling for genomic sequencing and analysis. It is not an HPH Cybersecurity Framework profile and is not NIST IR 8473.
    Why it matters
    Organizations handling genomic sequencing and analysis can use the example to inform workflow-specific threat modeling. Do not use it as an authoritative HIPAA, HICP, IEC 80001-1 or HPH-CPG crosswalk.
    Common pitfalls
    • •Do not confuse CSWP 35 with IR 8473.
    • •Label the located CSWP 35 edition as an initial public draft, not a final standard.
    • •Do not infer healthcare regulatory crosswalks or compliance from a genomic workflow example.
    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.