IEC 81001-5-1:2021 "Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle" is the international standard that specifies secure-development-lifecycle activities applicable to health software and software-containing medical devices. It maps onto IEC 62304's software lifecycle and is the most widely cited Secure Product Development Framework (SPDF) in MedTech cybersecurity submissions.

Why it matters

Most MedTech teams pursuing global submissions are aligning their development procedures to IEC 81001-5-1 and combining it with IEC 62304 for software safety and ISO 14971 for risk management. The three together form the operating system of a modern MedTech software program.

Common pitfalls

•Adopting 81001-5-1 on paper without integrating its activities into design reviews and design history file artifacts.
•Treating 81001-5-1 as separate from 62304 - they're designed to interlock.

Sources

IEC 81001-5-1:2021 · ISO/IEC
FDA Cybersecurity Guidance (Sept 2023) · FDA
HSCC - Health Sector Coordinating Council · HSCC

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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.