Cryptographic agility is the architectural property that lets a system replace its cryptographic primitives - algorithms, key sizes, protocol versions - without redesign. For medical devices fielded for 10–20 years, crypto agility is essential because algorithms (e.g., SHA-1, RSA-1024, TLS 1.0) become deprecated long before the device is retired. NIST's Post-Quantum Cryptography (PQC) program (FIPS 203/204/205, 2024) makes crypto agility newly urgent for any device whose data must remain confidential into the post-quantum era.

Why it matters

Achieving crypto agility means abstracting algorithms behind interfaces, supporting algorithm negotiation at every protocol layer, planning OTA updates that can deliver new crypto, and budgeting compute headroom for PQC algorithms (which have larger keys/signatures than ECC).

Common pitfalls

•Hardcoding cipher suites in firmware that cannot be updated.
•Choosing a hardware crypto accelerator that cannot be augmented with PQC algorithms.
•Treating crypto as 'set and forget' for a 15-year device lifetime.

Sources

NIST Post-Quantum Cryptography · NIST
NIST IR 8547 PQC Migration Guidance · NIST
FDA Cybersecurity Guidance (Sept 2023) · FDA

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.