OpenSSF framework defining progressive levels of build-system integrity for software supply chain security, focused on tamper-resistance of the build.

Definition

SLSA, Supply-chain Levels for Software Artifacts, is an industry-consensus software supply-chain security specification. Version 1.2 separates Build and Source tracks. Build levels L1, L2 and L3 progress from provenance availability to hosted-build authenticated provenance and hardened build-platform protections. The former four-level model, including Build Level 4, is obsolete.

Why it matters

SBOMs identify components; provenance records build origins and inputs. Verify provenance against trusted expectations. Neither proves the source is benign or prevents every upstream compromise, including attacks involving malicious authorized source changes.

Common pitfalls

•Equating SBOM with supply-chain security, without provenance, an SBOM can be fabricated.
•Choose a track and version before setting a target. Start with Build L1 provenance and progress toward L2 or L3 as appropriate, rather than targeting obsolete Build L4.
•Ignoring third-party SLSA provenance when selecting components, the framework's value compounds when consumed and produced.

Sources

SLSA Specification · OpenSSF
CISA - Healthcare and Public Health Sector · CISA
FDA - Cybersecurity for Medical Devices · FDA
SLSA v1.2 · OpenSSF
SLSA tracks · OpenSSF

Open full page

Select term B to compare.

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.