ISO 22301 specifies requirements to plan, establish, implement, operate, monitor, review, maintain, and continually improve a business continuity management system. Increasingly relevant for MedTech given EO supply, semiconductor, and contract-manufacturer disruptions. Business continuity planning helps MedTech companies meet expectations from regulators and hospital customers that critical devices remain available. ISO 22301 requires business impact analysis, risk assessment, continuity strategies, exercises and testing. It is not a medical device standard, but it ties into supplier controls under ISO 13485 and the FDA's notification requirements for device shortages under section 506J of the FD&C Act.

Why it matters

Hospital procurement teams and FDA shortage staff are both paying more attention to BCMS evidence from critical-device manufacturers.

Common pitfalls

•A common pitfall is treating ISO 22301 compliance as a checkbox exercise rather than integrating it deeply into the overall quality management system.
•Another mistake is failing to regularly test and update the business continuity plan, rendering it ineffective during an actual disruption.
•Organizations often overlook the importance of communication strategies during a crisis, leading to confusion and delayed responses.
•Some companies incorrectly assume that simply having an off-site backup for data constitutes a comprehensive business continuity plan.

Sources

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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.