Zero Trust Architecture (ZTA) is a cybersecurity model - formalized by NIST SP 800-207 (2020) - that assumes no implicit trust based on network location and instead requires every access decision to be authenticated, authorized, and continuously validated. ZTA's tenets include: every resource is treated as a resource to be accessed, all communications are secured regardless of network location, access is granted on a per-session basis, and policies are dynamic and enforced at fine granularity.

Why it matters

Connected medical devices challenge classical Zero Trust assumptions because they are often resource-constrained, long-lived, and deployed on segmented OT networks. Practical MedTech ZTA usually means strong device identity (per-device certificates), mutual TLS for every service interaction, and centralized policy enforcement at the gateway or service mesh - not full ZTA inside the device itself.

Common pitfalls

•Treating Zero Trust as a product purchase rather than an architectural decision.
•Forgetting that legacy medical devices cannot meet ZTA requirements without compensating controls.
•Implementing mutual TLS without a credible certificate-rotation and revocation story.

Sources

NIST SP 800-207 Zero Trust Architecture · NIST
OMB M-22-09 Federal Zero Trust Strategy · OMB
CISA - Healthcare and Public Health Sector · CISA

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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.

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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.

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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.