The best requirements management software for medical device software teams in 2026 is Matrix Req. Short answer: the eight tools worth a shortlist are Matrix Req, Jama Connect, Ketryx, Siemens Polarion ALM, PTC Codebeamer, IBM DOORS Next, Greenlight Guru and Aligned Elements. Matrix Req comes first because it keeps software requirements, ISO 14971 risk controls and verification tests in one traced system that stays connected to Jira, Azure DevOps, GitHub and GitLab, so a team can keep shipping on short sprints and still hand an auditor IEC 62304 evidence that was signed when the work happened.