├── .github └── workflows │ ├── documents.yml │ ├── publish.yml │ └── tests.yml ├── .gitignore ├── LICENSE.txt ├── README.md ├── contrib ├── README.md ├── convert_requirements.py ├── download_images.py ├── format_packages.py └── github_workflow.yml ├── docs ├── FAQ.md ├── HISTORY.md ├── checklist-format.md └── images │ ├── insert-form.png │ ├── select-docproperty-field.png │ └── select-property.png ├── rdm ├── __init__.py ├── checklists │ ├── 14971_2007.txt │ ├── 14971_2019.txt │ ├── 62304_2006_class_a.txt │ ├── 62304_2006_class_b.txt │ ├── 62304_2006_class_c.txt │ ├── 62304_2015_class_a.txt │ ├── 62304_2015_class_b.txt │ ├── 62304_2015_class_c.txt │ ├── 62304_base_class_a.txt │ ├── 62304_base_class_b.txt │ ├── 62304_base_class_c.txt │ ├── FDA-CYBER_2018.txt │ ├── FDA-HFE_2011.txt │ ├── FDA-SW_2005.txt │ ├── FDA-SW_2021_basic.txt │ └── FDA-SW_2021_enhanced.txt ├── collect.py ├── first_pass_output.py ├── gaps.py ├── hook_files │ ├── commit-msg │ └── prepare-commit-msg ├── hooks.py ├── init.py ├── init_files │ ├── .gitignore │ ├── Dockerfile │ ├── Makefile │ ├── config.yml │ ├── data │ │ ├── definitions.yml │ │ ├── device.yml │ │ ├── history.yml │ │ ├── integration_test_record.yml │ │ ├── manual_tests.yml │ │ ├── people.yml │ │ ├── predicate.yml │ │ ├── requirements.yml │ │ ├── risk.yml │ │ ├── soup.yml │ │ ├── unit_test_record.yml │ │ ├── versions.yml │ │ └── workflow.yml │ ├── docker-compose.yml │ ├── documents │ │ ├── 510k │ │ │ ├── 00_overview.md │ │ │ ├── 09_declarations_of_conformity_and_summary_reports.md │ │ │ ├── 11_executive_summary_predicate_comparison.md │ │ │ ├── 12_substantial_equivalence_discussion.md │ │ │ └── regulatory_change_assessment.md │ │ ├── cyber_security.md │ │ ├── documentation_level_evaluation.md │ │ ├── note_about_missing_requirements.md │ │ ├── revision_level_history.md │ │ ├── risk_assessment.md │ │ ├── risk_management_plan.md │ │ ├── risk_management_report.md │ │ ├── software_description.md │ │ ├── software_design_specification.md │ │ ├── software_development_and_maintenance_practices.md │ │ ├── software_development_and_maintenance_record.md │ │ ├── software_plan.md │ │ ├── software_release_activity_record.md │ │ ├── software_requirements_specification.md │ │ ├── system_and_software_architecture_diagram.md │ │ ├── test_record.md │ │ ├── unresolved_anomalies.md │ │ └── verification_and_validation_plan.md │ ├── images │ │ ├── lifecycle-processes.png │ │ └── uimockups │ │ │ ├── example-ui-mockup-001.png │ │ │ └── example-ui-mockup-002.jpg │ ├── pandoc_docx.yml │ ├── pandoc_pdf.yml │ └── template.tex ├── main.py ├── md_extensions │ ├── __init__.py │ ├── audit_notes.py │ ├── base.py │ ├── section_numbers.py │ └── vocabulary_extension.py ├── project_management │ ├── __init__.py │ ├── base.py │ └── github.py ├── pull.py ├── render.py ├── test_formatters │ ├── __init__.py │ └── xml_util.py ├── translate.py ├── util.py └── version.py ├── setup.cfg ├── setup.py └── tests ├── __init__.py ├── audit_notes_test.py ├── 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