rdm：我们的法规文件经理。 简化软件项目的62304、14971和510（k）文档
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2021-02-04
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rdm：我们的法规文件经理。 简化软件项目的62304、14971和510（k）文档 （105个子文件） 
setup.cfg 26B commit-msg 357B .gitignore 124B .gitignore 18B tox.ini 407B
example-ui-mockup-003.jpg 14KB Makefile 745B software_plan.md 42KB software_plan.md 38KB software_plan.md 22KB README.md 15KB software_requirements_specification.md 6KB software_requirements_specification.md 6KB software_design_specification.md 4KB level_of_concern.md 3KB release_history.md 3KB test_record.md 3KB release_record.md 1KB 510k.md 776B FAQ.md 520B hazard_analysis.md 365B architecture_design_chart.md 215B software_description.md 204B known_anomalies.md 190B cyber_security.md 94B
software_plan.pdf 205KB software_requirements_specification.pdf 182KB
example-ui-mockup-001.png 2KB prepare-commit-msg 537B github.py 11KB doctor.py 8KB audit_for_gaps.py 8KB tex.py 7KB audit_for_gaps_test.py 6KB audit_notes_test.py 6KB main.py 4KB util.py 4KB render.py 4KB audit_notes.py 3KB test_xml_util.py 3KB hook_test.py 3KB doctor_test.py 3KB xml_util.py 2KB section_number_test.py 2KB vocabulary_test.py 2KB collect.py 2KB setup.py 2KB base.py 2KB first_pass_output_test.py 2KB render_test.py 1KB fresh_release_test.py 1KB vocabulary_extension.py 1KB collect_test.py 1KB section_numbers.py 1KB translate.py 1KB extract_yaml_front_matter_test.py 914B util.py 781B first_pass_output.py 762B pull.py 758B extensions_test.py 712B util_test.py 579B install_hooks_test.py 540B hooks.py 436B pull_github_test.py 374B __init__.py 330B init.py 196B __init__.py 187B base.py 176B __init__.py 0B __init__.py 0B __init__.py 0B
lifecycle-processes.svg 22KB example-ui-mockup-002.svg 342B
62304_base_class_a.txt 6KB 62304_base_class_b.txt 4KB 14971_2007.txt 2KB 62304_base_class_c.txt 2KB FDA-GPSV_2005.txt 1KB LICENSE.txt 1KB FDA-HFE_2011.txt 1004B 62304_2006_class_a.txt 768B 62304_2015_class_b.txt 743B 62304_2006_class_b.txt 734B 62304_2015_class_a.txt 665B 62304_2015_class_c.txt 402B 62304_2006_class_c.txt 392B simple_checklist.txt 178B included_checklist.txt 155B test_detail.xml 2KB xunit_result.xml 2KB integration.xml 2KB fda.yml 10KB system.yml 2KB risk.yml 2KB definitions.yml 2KB 13485.yml 1KB requirements.yml 1KB history.yml 1KB config.yml 537B integration_test_record.yml 500B共 105 条
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