ISO/IEC 23894:2023 provides AI-specific guidance on risk management aligned with ISO 31000, addressing risks unique to AI such as bias, opacity, data drift, and autonomy. It adapts ISO 31000's process to AI, with annexes mapping AI-specific risk sources and lifecycle stages. It is not specific to medical devices, so MedTech teams often use it alongside ISO 14971 and AAMI TIR34971 (application of ISO 14971 to machine learning) to cover AI-related risks in product safety. It is also referenced in work toward harmonised standards that support the EU AI Act.

Why it matters

Often used alongside ISO 14971 for medical AI: 14971 covers patient harm; 23894 broadens to organizational and AI-system risks. Helpful for EU AI Act conformity narratives.

Common pitfalls

•A common pitfall is to apply ISO/IEC 23894:2023 in isolation, neglecting essential medical device risk management standards such as ISO 14971:2019.
•Organizations may mistakenly believe that addressing AI-specific risks under ISO/IEC 23894:2023 fully covers all safety and performance requirements for medical AI.
•Failing to integrate the risk management processes outlined in ISO/IEC 23894:2023 with the overall quality management system, as required by standards like 21 CFR Part 820, can lead to compliance gaps.
•Overlooking the need for continuous monitoring and post-market surveillance of AI systems to detect and mitigate emerging risks not identified during initial risk assessment is a significant oversight.
•Another pitfall is to narrowly interpret "risk" solely as patient harm, ignoring financial, reputational, or societal risks that ISO/IEC 23894:2023 aims to address.

Sources

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.