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# 9 best requirements management tools for medical device development (2026)

**[The Next Web](https://daily.dev/sources/tnw)** · 22 min read · 0 upvotes · 0 comments

## Summary

A ranked comparison of nine requirements management tools for medical device development, evaluated on traceability, regulatory compliance support, and audit readiness. Jama Connect tops the list for its governed Live Traceability, fast setup with preloaded medical device frameworks, and AI capabilities that operate within controlled workflows. Visure Requirements excels at compliance-heavy documentation, PTC Codebeamer suits software-centric ALM, Perforce Helix ALM unifies requirements and test management, and Siemens Polarion fits teams in the Siemens PLM ecosystem. Modern Requirements extends Azure DevOps, Ketryx automates AI-generated compliance artifacts, Altium Requirements Portal links requirements to engineering design data, and IBM DOORS Next serves legacy enterprise deployments. Key buying criteria include live governed traceability, built-in ISO 14971 risk management, coverage beyond software, standards support (IEC 62304, ISO 13485, FDA 21 CFR Part 11, EU MDR), and governed AI capabilities.

## Full article

daily.dev links to this article rather than hosting it. Read it at the original source: <https://thenextweb.com/news/best-requirements-management-tools-medical-device-2026>

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Tags: [#regulatory-compliance](https://daily.dev/tags/regulatory-compliance)

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