Coordinated Vulnerability Disclosure (CVD) is the documented process by which a manufacturer accepts vulnerability reports from external researchers, validates and remediates the issues, and publishes advisories - coordinated to give operators time to deploy fixes before attackers exploit them. ISO/IEC 29147:2018 defines the disclosure process and ISO/IEC 30111:2019 defines the internal handling process. FDA, CISA, and ENISA all expect MedTech manufacturers to operate a CVD program.

Why it matters

A working CVD program needs a published security.txt file or vendor security page, a monitored intake address (security@), an SLA-driven triage process, integration with CAPA, and a coordinated-release plan with affected customers and ISACs. Mature MedTech teams also offer Safe Harbor language so good-faith researchers aren't deterred by legal risk.

Common pitfalls

•No published intake channel - researchers default to public disclosure when they can't reach you.
•Treating CVD intake as a security-only problem; legal, comms, and clinical-affairs all need playbooks.
•Publishing advisories without a working VEX/SBOM bridge so operators know which devices need action.

Sources

ISO/IEC 29147:2018 - Vulnerability disclosure · ISO/IEC
ISO/IEC 30111:2019 - Vulnerability handling processes · ISO/IEC
FDA Cybersecurity Guidance (Sept 2023) · FDA
RFC 9116 - security.txt · IETF

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.