Static Application Security Testing (SAST) analyzes source code, bytecode, or binaries without executing them, looking for known vulnerable patterns (SQL injection, buffer overflows, hardcoded secrets, insecure crypto). Dynamic Application Security Testing (DAST) probes a running application from the outside, exercising authenticated and unauthenticated paths to find runtime issues (auth bypass, injection, misconfiguration). Together they cover complementary parts of the OWASP testing surface and are baseline tooling for any modern CI/CD pipeline.

Why it matters

SAST belongs in the developer's PR check (Semgrep, CodeQL, SonarQube, Checkmarx). DAST belongs in nightly or release-gate CI (OWASP ZAP, Burp Suite, Invicti). Both produce noise; mature teams tune rule sets, baseline known issues, and route real findings into the CAPA and security-fix workflow rather than dumping the raw tool output into the submission.

Common pitfalls

•Submitting raw tool output without triage - reviewers cannot tell signal from noise.
•Running SAST/DAST only at submission rather than continuously through the build pipeline.
•Skipping SCA (Software Composition Analysis) - SAST finds your code's bugs, SCA finds your dependencies' bugs.

Sources

FDA Cybersecurity Guidance (Sept 2023) · FDA
NIST SP 800-218 (SSDF) · NIST
OWASP ASVS (project repository) · OWASP

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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.