[
  {
    "standard": "qmsr",
    "atomStandard": "iso_13485",
    "id": "REQ-ISO13485-4.1.4",
    "slug": "req-iso13485-4-1-4",
    "title": "Control of Changes to QMS Processes",
    "regime_keys": {
      "iso-13485-2016": "4.1.4",
      "21-cfr-820-qsr": "820.70(b)",
      "21-cfr-820-qmsr-2026": "820.10 (incorporates ISO 13485 § 4.1.4)"
    },
    "url": "/crosswalk/qmsr/req-iso13485-4-1-4"
  },
  {
    "standard": "qmsr",
    "atomStandard": "iso_13485",
    "id": "REQ-ISO13485-4.2.5",
    "slug": "req-iso13485-4-2-5",
    "title": "Control of Records",
    "regime_keys": {
      "iso-13485-2016": "4.2.5",
      "21-cfr-820-qsr": "820.180",
      "21-cfr-820-qmsr-2026": "820.35; 820.10 (incorporates ISO 13485 § 4.2.5)"
    },
    "url": "/crosswalk/qmsr/req-iso13485-4-2-5"
  },
  {
    "standard": "qmsr",
    "atomStandard": "iso_13485",
    "id": "REQ-ISO13485-6.2",
    "slug": "req-iso13485-6-2",
    "title": "Human Resources / Training",
    "regime_keys": {
      "iso-13485-2016": "6.2",
      "21-cfr-820-qsr": "820.25",
      "21-cfr-820-qmsr-2026": "820.10 (incorporates ISO 13485 § 6.2)"
    },
    "url": "/crosswalk/qmsr/req-iso13485-6-2"
  },
  {
    "standard": "qmsr",
    "atomStandard": "iso_13485",
    "id": "REQ-ISO13485-7.3.3",
    "slug": "req-iso13485-7-3-3",
    "title": "Design and Development Inputs",
    "regime_keys": {
      "iso-13485-2016": "7.3.3",
      "iso-14971-2019": "5.4",
      "21-cfr-820-qsr": "820.30(c)",
      "21-cfr-820-qmsr-2026": "820.10 (incorporates ISO 13485 § 7.3.3)"
    },
    "url": "/crosswalk/qmsr/req-iso13485-7-3-3"
  },
  {
    "standard": "qmsr",
    "atomStandard": "iso_13485",
    "id": "REQ-ISO13485-7.3.8",
    "slug": "req-iso13485-7-3-8",
    "title": "Design Transfer",
    "regime_keys": {
      "iso-13485-2016": "7.3.8",
      "iso-14971-2019": "7.5",
      "21-cfr-820-qsr": "820.30(h)",
      "21-cfr-820-qmsr-2026": "820.10 (incorporates ISO 13485 § 7.3.8)"
    },
    "url": "/crosswalk/qmsr/req-iso13485-7-3-8"
  },
  {
    "standard": "qmsr",
    "atomStandard": "iso_13485",
    "id": "REQ-ISO13485-7.5.2",
    "slug": "req-iso13485-7-5-2",
    "title": "Cleanliness of Product",
    "regime_keys": {
      "iso-13485-2016": "7.5.2",
      "21-cfr-820-qsr": "820.70(e)",
      "21-cfr-820-qmsr-2026": "820.10 (incorporates ISO 13485 §7.5.2)"
    },
    "url": "/crosswalk/qmsr/req-iso13485-7-5-2"
  },
  {
    "standard": "qmsr",
    "atomStandard": "iso_13485",
    "id": "REQ-ISO13485-7.5.7",
    "slug": "req-iso13485-7-5-7",
    "title": "Particular Requirements for Validation of Processes for Sterilization and Sterile Barrier Systems",
    "regime_keys": {
      "iso-13485-2016": "7.5.7",
      "21-cfr-820-qsr": "820.75",
      "21-cfr-820-qmsr-2026": "820.10 (incorporates ISO 13485 §7.5.7)"
    },
    "url": "/crosswalk/qmsr/req-iso13485-7-5-7"
  },
  {
    "standard": "qmsr",
    "atomStandard": "iso_13485",
    "id": "REQ-ISO13485-8.2.4",
    "slug": "req-iso13485-8-2-4",
    "title": "Internal Audit",
    "regime_keys": {
      "iso-13485-2016": "8.2.4",
      "21-cfr-820-qsr": "820.22",
      "21-cfr-820-qmsr-2026": "820.10 (incorporates ISO 13485 § 8.2.4)"
    },
    "url": "/crosswalk/qmsr/req-iso13485-8-2-4"
  },
  {
    "standard": "qmsr",
    "atomStandard": "iso_13485",
    "id": "REQ-QMSR-820.30j",
    "slug": "req-qmsr-820-30j",
    "title": "Design History File (DHF)",
    "regime_keys": {
      "iso-13485-2016": "7.3",
      "21-cfr-820-qsr": "820.30(j)",
      "21-cfr-820-qmsr-2026": "820.10(c) (incorporates ISO 13485 § 7.3.10 design and development file — pre-QMSR DHF concept)"
    },
    "url": "/crosswalk/qmsr/req-qmsr-820-30j"
  },
  {
    "standard": "iec-62304",
    "atomStandard": "iec_62304",
    "id": "REQ-IEC62304-4.3",
    "slug": "req-iec62304-4-3",
    "title": "Software Safety Classification",
    "regime_keys": {
      "iec-62304-2015": "4.3",
      "iso-13485-2016": "7.3.2",
      "21-cfr-820-qsr": "820.30(b)"
    },
    "url": "/crosswalk/iec-62304/req-iec62304-4-3"
  },
  {
    "standard": "iec-62304",
    "atomStandard": "iec_62304",
    "id": "REQ-IEC62304-5.1",
    "slug": "req-iec62304-5-1",
    "title": "Software Development Planning",
    "regime_keys": {
      "iec-62304-2015": "5.1",
      "iso-13485-2016": "7.3.2",
      "21-cfr-820-qsr": "820.30(b)"
    },
    "url": "/crosswalk/iec-62304/req-iec62304-5-1"
  },
  {
    "standard": "iec-62304",
    "atomStandard": "iec_62304",
    "id": "REQ-IEC62304-5.4.3",
    "slug": "req-iec62304-5-4-3",
    "title": "Develop Detailed Design for Software Unit Interfaces",
    "regime_keys": {
      "iec-62304-2015": "5.4.3",
      "iso-13485-2016": "7.3.4",
      "21-cfr-820-qsr": "820.30(d)"
    },
    "url": "/crosswalk/iec-62304/req-iec62304-5-4-3"
  },
  {
    "standard": "iec-62304",
    "atomStandard": "iec_62304",
    "id": "REQ-IEC62304-5.6.3",
    "slug": "req-iec62304-5-6-3",
    "title": "Software Integration Testing",
    "regime_keys": {
      "iec-62304-2015": "5.6.3",
      "iso-13485-2016": "7.3.6",
      "21-cfr-820-qsr": "820.30(f)"
    },
    "url": "/crosswalk/iec-62304/req-iec62304-5-6-3"
  },
  {
    "standard": "iec-62304",
    "atomStandard": "iec_62304",
    "id": "REQ-IEC62304-5.7",
    "slug": "req-iec62304-5-7",
    "title": "Software System Testing",
    "regime_keys": {
      "iec-62304-2015": "5.7",
      "iso-13485-2016": "7.3.6",
      "21-cfr-820-qsr": "820.30(f)"
    },
    "url": "/crosswalk/iec-62304/req-iec62304-5-7"
  },
  {
    "standard": "iec-62366",
    "atomStandard": "iec_62366",
    "id": "REQ-IEC62366-4.1.1",
    "slug": "req-iec62366-4-1-1",
    "title": "Usability Engineering Process",
    "regime_keys": {
      "iec-62366-1-2020": "4.1.1",
      "iso-13485-2016": "7.3.2",
      "21-cfr-820-qsr": "820.30(b)"
    },
    "url": "/crosswalk/iec-62366/req-iec62366-4-1-1"
  },
  {
    "standard": "iec-62366",
    "atomStandard": "iec_62366",
    "id": "REQ-IEC62366-5.3",
    "slug": "req-iec62366-5-3",
    "title": "Identify known or foreseeable Hazards and Hazardous Situations",
    "regime_keys": {
      "iec-62366-1-2020": "5.3",
      "iso-13485-2016": "7.1",
      "21-cfr-820-qsr": "820.30(g)"
    },
    "url": "/crosswalk/iec-62366/req-iec62366-5-3"
  },
  {
    "standard": "iso-14971",
    "atomStandard": "iso_14971",
    "id": "REQ-ISO14971-10",
    "slug": "req-iso14971-10",
    "title": "Production and Post-Production Information Review",
    "regime_keys": {
      "iso-14971-2019": "10",
      "iso-13485-2016": "8.2.1",
      "21-cfr-820-qsr": "820.198"
    },
    "url": "/crosswalk/iso-14971/req-iso14971-10"
  },
  {
    "standard": "iso-14971",
    "atomStandard": "iso_14971",
    "id": "REQ-ISO14971-5.4",
    "slug": "req-iso14971-5-4",
    "title": "Hazard Identification and Risk Estimation",
    "regime_keys": {
      "iso-14971-2019": "5.4, 5.5",
      "iso-13485-2016": "7.1",
      "21-cfr-820-qsr": "820.30(g)"
    },
    "url": "/crosswalk/iso-14971/req-iso14971-5-4"
  },
  {
    "standard": "iec-81001",
    "atomStandard": "iec_81001",
    "id": "REQ-IEC81001-4.1.1",
    "slug": "req-iec81001-4-1-1",
    "title": "QMS and Security Responsibilities",
    "regime_keys": {
      "iec-81001-5-1-2021": "4.1.1, 4.1.2",
      "iso-13485-2016": "4.1"
    },
    "url": "/crosswalk/iec-81001/req-iec81001-4-1-1"
  },
  {
    "standard": "iec-81001",
    "atomStandard": "iec_81001",
    "id": "REQ-IEC81001-4.1.7",
    "slug": "req-iec81001-4-1-7",
    "title": "Disclosing Security-Related Issues",
    "regime_keys": {
      "iec-81001-5-1-2021": "4.1.7",
      "iso-13485-2016": "7.2.3"
    },
    "url": "/crosswalk/iec-81001/req-iec81001-4-1-7"
  },
  {
    "standard": "iec-81001",
    "atomStandard": "iec_81001",
    "id": "REQ-IEC81001-5.1.3",
    "slug": "req-iec81001-5-1-3",
    "title": "Secure Coding Standards Planning",
    "regime_keys": {
      "iec-81001-5-1-2021": "5.1.3"
    },
    "url": "/crosswalk/iec-81001/req-iec81001-5-1-3"
  },
  {
    "standard": "iec-81001",
    "atomStandard": "iec_81001",
    "id": "REQ-IEC81001-5.3.3",
    "slug": "req-iec81001-5-3-3",
    "title": "Security Architectural Design Review",
    "regime_keys": {
      "iec-81001-5-1-2021": "5.3.3"
    },
    "url": "/crosswalk/iec-81001/req-iec81001-5-3-3"
  },
  {
    "standard": "iec-81001",
    "atomStandard": "iec_81001",
    "id": "REQ-IEC81001-5.7.1",
    "slug": "req-iec81001-5-7-1",
    "title": "Security Requirements Testing",
    "regime_keys": {
      "iec-81001-5-1-2021": "5.7.1"
    },
    "url": "/crosswalk/iec-81001/req-iec81001-5-7-1"
  },
  {
    "standard": "iec-81001",
    "atomStandard": "iec_81001",
    "id": "REQ-IEC81001-5.8.1",
    "slug": "req-iec81001-5-8-1",
    "title": "Pre-Release Security Verification",
    "regime_keys": {
      "iec-81001-5-1-2021": "5.8.1"
    },
    "url": "/crosswalk/iec-81001/req-iec81001-5-8-1"
  },
  {
    "standard": "iec-81001",
    "atomStandard": "iec_81001",
    "id": "REQ-IEC81001-6.2.2",
    "slug": "req-iec81001-6-2-2",
    "title": "Security Update Verification",
    "regime_keys": {
      "iec-81001-5-1-2021": "6.2.2",
      "iec-62304-2015": "6.2"
    },
    "url": "/crosswalk/iec-81001/req-iec81001-6-2-2"
  },
  {
    "standard": "iec-81001",
    "atomStandard": "iec_81001",
    "id": "REQ-IEC81001-7.5",
    "slug": "req-iec81001-7-5",
    "title": "Monitoring Risk Control Effectiveness",
    "regime_keys": {
      "iec-81001-5-1-2021": "7.5",
      "iso-14971-2019": "10"
    },
    "url": "/crosswalk/iec-81001/req-iec81001-7-5"
  },
  {
    "standard": "cybersecurity",
    "atomStandard": "cybersecurity",
    "id": "REQ-FDACYBER-ANOMALIES",
    "slug": "req-fdacyber-anomalies",
    "title": "Security Assessment of Unresolved Software Anomalies",
    "regime_keys": {
      "fda-cybersecurity-guidance-2026-02": "V.A.5"
    },
    "url": "/crosswalk/cybersecurity/req-fdacyber-anomalies"
  },
  {
    "standard": "cybersecurity",
    "atomStandard": "cybersecurity",
    "id": "REQ-FDACYBER-CVD",
    "slug": "req-fdacyber-cvd",
    "title": "Coordinated Vulnerability Disclosure",
    "regime_keys": {
      "fda-cybersecurity-guidance-2026-02": "VI.B, VII.C.1",
      "iec-81001-5-1-2021": "9",
      "21-cfr-820-qsr": "820.198"
    },
    "url": "/crosswalk/cybersecurity/req-fdacyber-cvd"
  },
  {
    "standard": "cybersecurity",
    "atomStandard": "cybersecurity",
    "id": "REQ-FDACYBER-PATCH",
    "slug": "req-fdacyber-patch",
    "title": "Patch and Update Management Plan",
    "regime_keys": {
      "fda-cybersecurity-guidance-2026-02": "Appendix 1.H, VI.B, VII.D",
      "iec-81001-5-1-2021": "6",
      "iec-62304-2015": "6.2",
      "21-cfr-820-qsr": "820.90"
    },
    "url": "/crosswalk/cybersecurity/req-fdacyber-patch"
  },
  {
    "standard": "cybersecurity",
    "atomStandard": "cybersecurity",
    "id": "REQ-FDACYBER-VULN",
    "slug": "req-fdacyber-vuln",
    "title": "Vulnerability Assessment and Management",
    "regime_keys": {
      "fda-cybersecurity-guidance-2026-02": "V.A.6, VI.B, VII.C.2",
      "iec-81001-5-1-2021": "6",
      "iec-62304-2015": "6.2",
      "21-cfr-820-qsr": "820.90"
    },
    "url": "/crosswalk/cybersecurity/req-fdacyber-vuln"
  }
]