CROSSWALK
Requirements by Discipline
Requirements from all standards, grouped by subject discipline — quality management, risk, software lifecycle, cybersecurity, and usability engineering.
184 requirements across all standards. Browse by standard →
Quality Management
66 requirements across all standards
| Standard | Clause | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| IEC 81001-5-1 | §4.1.1, 4.1.2 | QMS and Security Responsibilities | 1 | View → |
| IEC 81001-5-1 | §4.1.3 | Identification of Applicability | 1 | View → |
| IEC 81001-5-1 | §4.1.4 | Security Expertise and Training | 1 | View → |
| IEC 81001-5-1 | §4.1.6, 4.1.8 | Continuous Improvement and Periodic Review | 1 | View → |
| 21 CFR Postmarket | §803.10 | MDR Reporting Requirements — General Obligations | — | — |
| 21 CFR Postmarket | §803.17 | Written MDR Procedures | — | — |
| 21 CFR Postmarket | §803.18 | MDR Event Files and Records Retention | — | — |
| 21 CFR Postmarket | §803.50 | Manufacturer MDR Reporting — Adverse Event Investigation and Submission | — | — |
| 21 CFR Postmarket | §803.53 | 5-Day Expedited MDR Reports | — | — |
| 21 CFR Postmarket | §806.10 | Reports of Corrections and Removals | — | — |
| 21 CFR Postmarket | §806.20 | Records of Corrections and Removals Not Required to Be Reported | — | — |
| 21 CFR Postmarket | §806.30 | FDA Access to Corrections and Removals Records | — | — |
| 21 CFR Postmarket | §810.10, 810.15 | Cease Distribution and Notification Order — Compliance Obligations | — | — |
| 21 CFR Postmarket | §810.13, 810.14 | Mandatory Recall Order — Strategy and Status Reporting | — | — |
| 21 CFR Postmarket | §822.1, 822.4, 822.5, 822.8, 822.24 | Postmarket Surveillance Order — Applicability and Plan Submission | — | — |
| 21 CFR Postmarket | §822.10, 822.11, 822.15 | Postmarket Surveillance Plan Content Requirements | — | — |
| 21 CFR Postmarket | §822.31, 822.33, 822.35, 822.36, 822.38 | Postmarket Surveillance Records and Reporting Obligations | — | — |
| 21 CFR Postmarket | §822.26 | Postmarket Surveillance — Change of Ownership Notification | — | — |
| 21 CFR Postmarket | §822.27 | Postmarket Surveillance — Business Closure Notification | — | — |
| 21 CFR Postmarket | §822.28 | Postmarket Surveillance — Obligation Continues After Ceasing to Market | — | — |
| 21 CFR Postmarket | §822.34 | Postmarket Surveillance — Sponsor or Investigator Change Records Transfer | — | — |
| 21 CFR Postmarket | §803.56 | Manufacturer Supplemental and Followup MDR Reports | — | — |
| QMSR / ISO 13485 | §7.3.2 | Design and Development Planning | 5 | View → |
| QMSR / ISO 13485 | §7.3.3 | Design and Development Inputs | 5 | View → |
| QMSR / ISO 13485 | §7.3.5 | Design and Development Review | 5 | View → |
| QMSR / ISO 13485 | §5.6 | Management Review | 5 | View → |
| QMSR / ISO 13485 | §8.5.2, 8.5.3 | Corrective and Preventive Action (CAPA) | 5 | View → |
| QMSR / ISO 13485 | §8.2.2 | Complaint Handling | 5 | View → |
| QMSR / ISO 13485 | §4.2.4 | Document Control | 5 | View → |
| QMSR / ISO 13485 | §4.2.3 | Medical Device File | 4 | View → |
| QMSR / ISO 13485 | §7.4, 4.1.5 | Supplier Management | 5 | View → |
| QMSR / ISO 13485 | §7.3.4 | Design Outputs | 5 | View → |
| QMSR / ISO 13485 | §7.3.6 | Design Verification | 5 | View → |
| QMSR / ISO 13485 | §7.3.7 | Design Validation | 5 | View → |
| QMSR / ISO 13485 | §7.3.9 | Design Changes | 5 | View → |
| QMSR / ISO 13485 | §7.3.8 | Design Transfer | 4 | View → |
| QMSR / ISO 13485 | §7.5.6 | Process Validation | 5 | View → |
| QMSR / ISO 13485 | §8.2.4 | Internal Audit | 5 | View → |
| QMSR / ISO 13485 | §8.3 | Nonconforming Product | 5 | View → |
| QMSR / ISO 13485 | §6.2 | Human Resources / Training | 5 | View → |
| QMSR / ISO 13485 | §4.2.5 | Records Control | 5 | View → |
| QMSR / ISO 13485 | §7.5.1 | Labeling Controls | 5 | View → |
| QMSR / ISO 13485 | §4.2.5 | Control of Records | 5 | View → |
| QMSR / ISO 13485 | §8.2.1 | Feedback / Post-Market Surveillance | 3 | View → |
| QMSR / ISO 13485 | §8.2.3 | Regulatory Reporting | 5 | View → |
| QMSR / ISO 13485 | §8.4 | Analysis of Data | 5 | View → |
| QMSR / ISO 13485 | §5.3 | Quality Policy | 5 | View → |
| QMSR / ISO 13485 | §4.2.1, 4.2.2 | Quality Manual | 5 | View → |
| QMSR / ISO 13485 | §6.3 | Infrastructure and Equipment Maintenance | 5 | View → |
| QMSR / ISO 13485 | §6.4 | Work Environment and Contamination Control | 5 | View → |
| QMSR / ISO 13485 | §7.1 | Product Realization Planning and Quality Plan | 5 | View → |
| QMSR / ISO 13485 | §7.2 | Customer Requirements and Communication | 5 | View → |
| QMSR / ISO 13485 | §7.5.1 | Production Process Controls and Work Instructions | 5 | View → |
| QMSR / ISO 13485 | §7.5.8, 7.5.9 | Product Identification and Traceability | 5 | View → |
| QMSR / ISO 13485 | §7.5.11 | Product Preservation — Handling, Packaging, and Storage | 5 | View → |
| QMSR / ISO 13485 | §7.6 | Calibration — Control of Monitoring and Measuring Equipment | 5 | View → |
| QMSR / ISO 13485 | §7.3 | Design History File (DHF) | 5 | View → |
| QMSR / ISO 13485 | §4.2.3 | Device Master Record (DMR) and Device History Record (DHR) | 5 | View → |
| QMSR / ISO 13485 | §8.2.6, 7.4.3 | Acceptance Activities — Receiving, In-Process, and Finished Device Release | 5 | View → |
| QMSR / ISO 13485 | §5.4.1, 5.4.2 | Quality Objectives and QMS Planning | 5 | View → |
| QMSR / ISO 13485 | §5.5.1, 5.5.2, 5.5.3 | Responsibility, Authority, and Communication | 5 | View → |
| QMSR / ISO 13485 | §7.5.2 | Cleanliness of Product | 3 | View → |
| QMSR / ISO 13485 | §7.5.3 | Installation Activities | 3 | View → |
| QMSR / ISO 13485 | §7.5.4 | Servicing Activities | 3 | View → |
| QMSR / ISO 13485 | §7.5.10 | Customer Property | 3 | View → |
| QMSR / ISO 13485 | §4.1.4 | Control of Changes to QMS Processes | 4 | View → |
Risk Management
43 requirements across all standards
| Standard | Clause | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| FDA Cybersecurity | §V.A.1, V.B.2 | Threat Model Documentation | 1 | View → |
| FDA Cybersecurity | §V.A.2 | Cybersecurity Risk Assessment | 1 | View → |
| FDA Cybersecurity | §V.A.6, VI.B, VII.C.2 | Vulnerability Assessment and Management | 1 | View → |
| FDA Cybersecurity | §V.A.6, VI.B, VII.E | End-of-Life Cybersecurity Plan | 1 | View → |
| FDA Cybersecurity | §5.3.3 | SOUP Risk Assessment | 1 | View → |
| FDA Cybersecurity | §V.A.5 | Security Assessment of Unresolved Software Anomalies | 1 | View → |
| IEC 62304 | §4.3 | Software Safety Classification | 3 | View → |
| IEC 62304 | §5.2 | Software Requirements Analysis | 2 | View → |
| IEC 62304 | §5.7 | Software System Testing | 3 | View → |
| IEC 62304 | §7 | Software Risk Management | 1 | View → |
| IEC 62304 | §4.4.2 | Legacy Software Risk Management Activities | 2 | View → |
| IEC 62304 | §5.6.4 | Software Integration Testing Content | 2 | View → |
| IEC 62366 | §4.1.1 | Usability Engineering Process | 2 | View → |
| IEC 62366 | §5.3 | Identify known or foreseeable Hazards and Hazardous Situations | 2 | View → |
| IEC 62366 | §5.9 | Perform Summative Evaluation of the Usability of the User Interface | 4 | View → |
| IEC 62366 | §5.10 | User Interface of Unknown Provenance (UOUP) | — | View → |
| IEC 62366 | §4.1.2 | RISK CONTROL as it relates to USER INTERFACE design | 2 | View → |
| IEC 62366 | §4.1.3 | Information for SAFETY as it relates to USABILITY | 2 | View → |
| IEC 62366 | §5.2 | Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS | 2 | View → |
| IEC 62366 | §5.4 | Identify and describe HAZARD-RELATED USE SCENARIOS | 2 | View → |
| IEC 62366 | §5.5 | Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION | 2 | View → |
| IEC 81001-5-1 | §4.2 | Security Risk Management | 1 | View → |
| IEC 81001-5-1 | §4.3 | Software Item Classification for Risk Transfer | 1 | View → |
| IEC 81001-5-1 | §5.2.1 | Health Software Security Requirements | 1 | View → |
| IEC 81001-5-1 | §5.2.3 | Security Risks for Required Software | 1 | View → |
| IEC 81001-5-1 | §5.7.2 | Threat Mitigation Testing | 1 | View → |
| IEC 81001-5-1 | §7.1.1, 7.1.2 | Risk Management Context and Product Security Context | 1 | View → |
| IEC 81001-5-1 | §7.2 | Threat and Vulnerability Identification | 1 | View → |
| IEC 81001-5-1 | §7.3 | Security Risk Estimation and Evaluation | 1 | View → |
| IEC 81001-5-1 | §7.4 | Controlling Security Risks | 1 | View → |
| IEC 81001-5-1 | §7.5 | Monitoring Risk Control Effectiveness | 1 | View → |
| IEC 81001-5-1 | §9.4 | Analysing Vulnerabilities | 1 | View → |
| IEC 81001-5-1 | §9.5 | Addressing Security-Related Issues | 1 | View → |
| ISO 14971 | §4.1 | Risk Management Process | 3 | View → |
| ISO 14971 | §4.4 | Risk Management Plan | 2 | View → |
| ISO 14971 | §5.2 | Intended Use and Reasonably Foreseeable Misuse | 1 | View → |
| ISO 14971 | §5.4 | Hazard Identification and Risk Estimation | 2 | View → |
| ISO 14971 | §6 | Risk Evaluation Against Acceptability Criteria | 1 | View → |
| ISO 14971 | §7.1 | Risk Control Option Analysis | 2 | View → |
| ISO 14971 | §7.3 | Residual Risk Evaluation and Benefit-Risk Analysis | 2 | View → |
| ISO 14971 | §8 | Overall Residual Risk Evaluation and Risk Management Review | 1 | View → |
| ISO 14971 | §10 | Production and Post-Production Information Review | 2 | View → |
| QMSR / ISO 13485 | §7.1 | Risk Management | 5 | View → |
Software Lifecycle
70 requirements across all standards
| Standard | Clause | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| FDA Cybersecurity | §V.A.4, VII.C.3, Appendix 4 | Software Bill of Materials | 1 | View → |
| FDA Cybersecurity | §Appendix 1.H, VI.B, VII.D | Patch and Update Management Plan | 1 | View → |
| FDA Cybersecurity | §5.3.3, 5.3.4 | SOUP Identification and Management | 1 | View → |
| FDA Cybersecurity | §5.3.3 | SOUP Risk Assessment | 1 | View → |
| FDA Cybersecurity | §5.3.3 | SBOM Documentation and Maintenance | 1 | View → |
| FDA Cybersecurity | §6.2 | Vulnerability Monitoring and Response | 1 | View → |
| FDA Cybersecurity | §5.3.3 | Open Source License Compliance | 1 | View → |
| IEC 62304 | §4.3 | Software Safety Classification | 3 | View → |
| IEC 62304 | §5.1 | Software Development Planning | 2 | View → |
| IEC 62304 | §5.2 | Software Requirements Analysis | 2 | View → |
| IEC 62304 | §5.3 | Software Architectural Design | 3 | View → |
| IEC 62304 | §5.5 | Software unit implementation | 2 | View → |
| IEC 62304 | §5.7 | Software System Testing | 3 | View → |
| IEC 62304 | §5.8 | Software Release | 1 | View → |
| IEC 62304 | §6 | Software Maintenance | 2 | View → |
| IEC 62304 | §7 | Software Risk Management | 1 | View → |
| IEC 62304 | §8 | Software Configuration Management | 2 | View → |
| IEC 62304 | §9 | Software Problem Resolution | 1 | View → |
| IEC 62304 | §4.4.2 | Legacy Software Risk Management Activities | 2 | View → |
| IEC 62304 | §4.4.3 | Legacy Software Gap Analysis | 3 | View → |
| IEC 62304 | §4.4.4 | Legacy Software Gap Closure Activities | 2 | View → |
| IEC 62304 | §4.4.5 | Legacy Software Rationale for Continued Use | 2 | View → |
| IEC 62304 | §5.4.1 | Subdivide Software into Software Units | 2 | View → |
| IEC 62304 | §5.4.2 | Develop Detailed Design for Each Software Unit | 2 | View → |
| IEC 62304 | §5.4.3 | Develop Detailed Design for Software Unit Interfaces | 2 | View → |
| IEC 62304 | §5.4.4 | Verify Software Detailed Design | 2 | View → |
| IEC 62304 | §5.6.1 | Integrate Software Units | 2 | View → |
| IEC 62304 | §5.6.2 | Verify Software Integration | 2 | View → |
| IEC 62304 | §5.6.3 | Software Integration Testing | 2 | View → |
| IEC 62304 | §5.6.4 | Software Integration Testing Content | 2 | View → |
| IEC 62304 | §5.6.5 | Evaluate Software Integration Test Procedures | 2 | View → |
| IEC 62304 | §5.6.6 | Conduct Regression Tests During Integration | 2 | View → |
| IEC 62304 | §5.6.7 | Integration Test Record Contents | 3 | View → |
| IEC 81001-5-1 | §4.1.3 | Identification of Applicability | 1 | View → |
| IEC 81001-5-1 | §4.1.5 | Third-Party Supplier Security | 1 | View → |
| IEC 81001-5-1 | §4.1.9 | Accompanying Documentation Review | 1 | View → |
| IEC 81001-5-1 | §4.2 | Security Risk Management | 1 | View → |
| IEC 81001-5-1 | §4.3 | Software Item Classification for Risk Transfer | 1 | View → |
| IEC 81001-5-1 | §5.1.1 | Security Life Cycle Activities Planning | 1 | View → |
| IEC 81001-5-1 | §5.1.2 | Development Environment Security | 1 | View → |
| IEC 81001-5-1 | §5.1.3 | Secure Coding Standards Planning | 1 | View → |
| IEC 81001-5-1 | §5.2.1 | Health Software Security Requirements | 1 | View → |
| IEC 81001-5-1 | §5.2.2 | Security Requirements Review | 1 | View → |
| IEC 81001-5-1 | §5.2.3 | Security Risks for Required Software | 1 | View → |
| IEC 81001-5-1 | §5.3.1 | Defense-in-Depth Architecture | 1 | View → |
| IEC 81001-5-1 | §5.3.2 | Secure Design Best Practices | 1 | View → |
| IEC 81001-5-1 | §5.3.3 | Security Architectural Design Review | 1 | View → |
| IEC 81001-5-1 | §5.4.1 | Secure Software Design | 1 | View → |
| IEC 81001-5-1 | §5.4.3 | Secure Health Software Interfaces | 1 | View → |
| IEC 81001-5-1 | §5.4.4 | Detailed Design Verification for Security | 1 | View → |
| IEC 81001-5-1 | §5.5.1 | Secure Coding and Implementation Review | 1 | View → |
| IEC 81001-5-1 | §5.6 | Security in Integration Testing | 1 | View → |
| IEC 81001-5-1 | §5.7.1 | Security Requirements Testing | 1 | View → |
| IEC 81001-5-1 | §5.7.2 | Threat Mitigation Testing | 1 | View → |
| IEC 81001-5-1 | §5.7.3 | Vulnerability Testing | 1 | View → |
| IEC 81001-5-1 | §5.7.4 | Penetration Testing | 1 | View → |
| IEC 81001-5-1 | §5.7.5 | Tester Independence | 1 | View → |
| IEC 81001-5-1 | §5.8.1 | Pre-Release Security Verification | 1 | View → |
| IEC 81001-5-1 | §5.8.2 | Security Release Documentation | 1 | View → |
| IEC 81001-5-1 | §5.8.3 | File Integrity and Private Key Controls | 1 | View → |
| IEC 81001-5-1 | §5.8.7 | Secure Decommissioning Guidelines | 1 | View → |
| IEC 81001-5-1 | §6.1.1 | Timely Security Update Policy | 1 | View → |
| IEC 81001-5-1 | §6.2.1 | Monitoring Public Incident Reports | 1 | View → |
| IEC 81001-5-1 | §6.2.2 | Security Update Verification | 1 | View → |
| IEC 81001-5-1 | §6.3.1, 6.3.2, 6.3.3 | Security Update Documentation and Delivery | 1 | View → |
| IEC 81001-5-1 | §7.1.1, 7.1.2 | Risk Management Context and Product Security Context | 1 | View → |
| IEC 81001-5-1 | §7.2 | Threat and Vulnerability Identification | 1 | View → |
| IEC 81001-5-1 | §8 | Software Configuration Management | 1 | View → |
| IEC 81001-5-1 | §9.3 | Reviewing Vulnerabilities | 1 | View → |
| IEC 81001-5-1 | §9.5 | Addressing Security-Related Issues | 1 | View → |
Cybersecurity
69 requirements across all standards
| Standard | Clause | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| FDA Cybersecurity | §V.A.1, V.B.2 | Threat Model Documentation | 1 | View → |
| FDA Cybersecurity | §V.A.2 | Cybersecurity Risk Assessment | 1 | View → |
| FDA Cybersecurity | §V.A.4, VII.C.3, Appendix 4 | Software Bill of Materials | 1 | View → |
| FDA Cybersecurity | §V.A.6, VI.B, VII.C.2 | Vulnerability Assessment and Management | 1 | View → |
| FDA Cybersecurity | §Appendix 1.H, VI.B, VII.D | Patch and Update Management Plan | 1 | View → |
| FDA Cybersecurity | §VI.B, VII.C.1 | Coordinated Vulnerability Disclosure | 1 | View → |
| FDA Cybersecurity | §V.A.6, VI.B, VII.E | End-of-Life Cybersecurity Plan | 1 | View → |
| FDA Cybersecurity | §V.C | Penetration Testing Evidence | 1 | View → |
| FDA Cybersecurity | §5.3.3, 5.3.4 | SOUP Identification and Management | 1 | View → |
| FDA Cybersecurity | §5.3.3 | SOUP Risk Assessment | 1 | View → |
| FDA Cybersecurity | §5.3.3 | SBOM Documentation and Maintenance | 1 | View → |
| FDA Cybersecurity | §6.2 | Vulnerability Monitoring and Response | 1 | View → |
| FDA Cybersecurity | §5.3.3 | Open Source License Compliance | 1 | View → |
| FDA Cybersecurity | §Appendix 1.A | Authentication Controls for Medical Devices | 1 | View → |
| FDA Cybersecurity | §Appendix 1.B | Authorization Controls and Least Privilege | 1 | View → |
| FDA Cybersecurity | §Appendix 1.C | Cryptography Selection and Implementation | 1 | View → |
| FDA Cybersecurity | §Appendix 1.D | Code, Data, and Execution Integrity | 1 | View → |
| FDA Cybersecurity | §Appendix 1.E | Confidentiality of Device Data and Credentials | 1 | View → |
| FDA Cybersecurity | §Appendix 1.F | Security Event Detection and Logging | 1 | View → |
| FDA Cybersecurity | §Appendix 1.G | Cyber Resiliency and Recovery Design | 1 | View → |
| FDA Cybersecurity | §V.A.3 | Interoperability Cybersecurity Considerations | 1 | View → |
| FDA Cybersecurity | §V.A.5 | Security Assessment of Unresolved Software Anomalies | 1 | View → |
| FDA Cybersecurity | §VI.A | Cybersecurity Labeling for Devices with Cybersecurity Risks | 1 | View → |
| IEC 81001-5-1 | §4.1.1, 4.1.2 | QMS and Security Responsibilities | 1 | View → |
| IEC 81001-5-1 | §4.1.3 | Identification of Applicability | 1 | View → |
| IEC 81001-5-1 | §4.1.4 | Security Expertise and Training | 1 | View → |
| IEC 81001-5-1 | §4.1.5 | Third-Party Supplier Security | 1 | View → |
| IEC 81001-5-1 | §4.1.6, 4.1.8 | Continuous Improvement and Periodic Review | 1 | View → |
| IEC 81001-5-1 | §4.1.7 | Disclosing Security-Related Issues | 1 | View → |
| IEC 81001-5-1 | §4.1.9 | Accompanying Documentation Review | 1 | View → |
| IEC 81001-5-1 | §4.2 | Security Risk Management | 1 | View → |
| IEC 81001-5-1 | §4.3 | Software Item Classification for Risk Transfer | 1 | View → |
| IEC 81001-5-1 | §5.1.1 | Security Life Cycle Activities Planning | 1 | View → |
| IEC 81001-5-1 | §5.1.2 | Development Environment Security | 1 | View → |
| IEC 81001-5-1 | §5.1.3 | Secure Coding Standards Planning | 1 | View → |
| IEC 81001-5-1 | §5.2.1 | Health Software Security Requirements | 1 | View → |
| IEC 81001-5-1 | §5.2.2 | Security Requirements Review | 1 | View → |
| IEC 81001-5-1 | §5.2.3 | Security Risks for Required Software | 1 | View → |
| IEC 81001-5-1 | §5.3.1 | Defense-in-Depth Architecture | 1 | View → |
| IEC 81001-5-1 | §5.3.2 | Secure Design Best Practices | 1 | View → |
| IEC 81001-5-1 | §5.3.3 | Security Architectural Design Review | 1 | View → |
| IEC 81001-5-1 | §5.4.1 | Secure Software Design | 1 | View → |
| IEC 81001-5-1 | §5.4.3 | Secure Health Software Interfaces | 1 | View → |
| IEC 81001-5-1 | §5.4.4 | Detailed Design Verification for Security | 1 | View → |
| IEC 81001-5-1 | §5.5.1 | Secure Coding and Implementation Review | 1 | View → |
| IEC 81001-5-1 | §5.6 | Security in Integration Testing | 1 | View → |
| IEC 81001-5-1 | §5.7.1 | Security Requirements Testing | 1 | View → |
| IEC 81001-5-1 | §5.7.2 | Threat Mitigation Testing | 1 | View → |
| IEC 81001-5-1 | §5.7.3 | Vulnerability Testing | 1 | View → |
| IEC 81001-5-1 | §5.7.4 | Penetration Testing | 1 | View → |
| IEC 81001-5-1 | §5.7.5 | Tester Independence | 1 | View → |
| IEC 81001-5-1 | §5.8.1 | Pre-Release Security Verification | 1 | View → |
| IEC 81001-5-1 | §5.8.2 | Security Release Documentation | 1 | View → |
| IEC 81001-5-1 | §5.8.3 | File Integrity and Private Key Controls | 1 | View → |
| IEC 81001-5-1 | §5.8.7 | Secure Decommissioning Guidelines | 1 | View → |
| IEC 81001-5-1 | §6.1.1 | Timely Security Update Policy | 1 | View → |
| IEC 81001-5-1 | §6.2.1 | Monitoring Public Incident Reports | 1 | View → |
| IEC 81001-5-1 | §6.2.2 | Security Update Verification | 1 | View → |
| IEC 81001-5-1 | §6.3.1, 6.3.2, 6.3.3 | Security Update Documentation and Delivery | 1 | View → |
| IEC 81001-5-1 | §7.1.1, 7.1.2 | Risk Management Context and Product Security Context | 1 | View → |
| IEC 81001-5-1 | §7.2 | Threat and Vulnerability Identification | 1 | View → |
| IEC 81001-5-1 | §7.3 | Security Risk Estimation and Evaluation | 1 | View → |
| IEC 81001-5-1 | §7.4 | Controlling Security Risks | 1 | View → |
| IEC 81001-5-1 | §7.5 | Monitoring Risk Control Effectiveness | 1 | View → |
| IEC 81001-5-1 | §8 | Software Configuration Management | 1 | View → |
| IEC 81001-5-1 | §9.2 | Receiving Vulnerability Notifications | 1 | View → |
| IEC 81001-5-1 | §9.3 | Reviewing Vulnerabilities | 1 | View → |
| IEC 81001-5-1 | §9.4 | Analysing Vulnerabilities | 1 | View → |
| IEC 81001-5-1 | §9.5 | Addressing Security-Related Issues | 1 | View → |
Usability Engineering
16 requirements across all standards
| Standard | Clause | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| IEC 62366 | §4.1.1 | Usability Engineering Process | 2 | View → |
| IEC 62366 | §4.2 | Usability Engineering File | 1 | View → |
| IEC 62366 | §5.1 | Use Specification | 1 | View → |
| IEC 62366 | §5.3 | Identify known or foreseeable Hazards and Hazardous Situations | 2 | View → |
| IEC 62366 | §5.7 | Establish User Interface Evaluation plan | 1 | View → |
| IEC 62366 | §5.9 | Perform Summative Evaluation of the Usability of the User Interface | 4 | View → |
| IEC 62366 | §5.10 | User Interface of Unknown Provenance (UOUP) | — | View → |
| IEC 62366 | §4.1.2 | RISK CONTROL as it relates to USER INTERFACE design | 2 | View → |
| IEC 62366 | §4.1.3 | Information for SAFETY as it relates to USABILITY | 2 | View → |
| IEC 62366 | §5.2 | Identify USER INTERFACE characteristics related to SAFETY and potential USE ERRORS | 2 | View → |
| IEC 62366 | §5.4 | Identify and describe HAZARD-RELATED USE SCENARIOS | 2 | View → |
| IEC 62366 | §5.5 | Select the HAZARD-RELATED USE SCENARIOS for SUMMATIVE EVALUATION | 2 | View → |
| IEC 62366 | §5.6 | Establish USER INTERFACE SPECIFICATION | 2 | View → |
| IEC 62366 | §5.8 | Perform USER INTERFACE design, implementation and FORMATIVE EVALUATION | 3 | View → |
| ISO 14971 | §5.2 | Intended Use and Reasonably Foreseeable Misuse | 1 | View → |
| QMSR / ISO 13485 | §7.3.3 | Design and Development Inputs | 5 | View → |
Sterilization
2 requirements across all standards
| Standard | Clause | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| QMSR / ISO 13485 | §7.5.5 | Particular Requirements for Sterile Medical Devices | 3 | View → |
| QMSR / ISO 13485 | §7.5.7 | Particular Requirements for Validation of Processes for Sterilization and Sterile Barrier Systems | 3 | View → |
Computerized Systems Validation & Data Integrity
1 requirement across all standards
| Standard | Clause | Requirement | Common Gaps | Details |
|---|---|---|---|---|
| QMSR / ISO 13485 | §4.1.6 | Validation of Computer Software Used in the QMS | 5 | View → |
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