Secure-by-design products eliminate entire classes of vulnerabilities through memory-safe languages, least-privilege design, default deny, and threat modeling at architecture phase. CISA promotes secure-by-design as a manufacturer responsibility. For medical devices, FDA's 2023 premarket cybersecurity guidance builds this into the Secure Product Development Framework (SPDF), expecting security architecture views, threat models, security risk management and an SBOM in submissions. Section 524B of the FD&C Act, in force since March 2023, makes these expectations legal requirements for cyber devices. The EU MDR's general safety and performance requirements also require state-of-the-art security.

Why it matters

Increasingly an expectation in FDA premarket cyber feedback and a procurement criterion for hospital IT.

Common pitfalls

•Failure to conduct thorough threat modeling early in the design process can lead to overlooked vulnerabilities and costly retrofits.
•Relying solely on post-market patching rather than integrating security into the initial design is a common pitfall.
•Assuming that general IT security practices are sufficient for medical devices without considering their unique safety and efficacy requirements is a mistake.
•Neglecting to implement least-privilege principles can lead to excessive access and expanded attack surfaces if a breach occurs.
•Failing to continually update and assess the security posture throughout the device

Sources

CISA Secure by Design · CISA
IMDRF - Software as a Medical Device · IMDRF
MDCG Software Guidance · MDCG

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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

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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.