Introduction to Medical Software

About Course

A Course by Yale University

Introduction to Medical Software, In this class, we present a broad overview of the field of medical software. You will learn from Yale professors and a series of industry experts who connect the course concepts to their real world applications. We begin by discussing medical device regulatory structures, data privacy and cybersecurity regulations, and key support technologies such quality management systems and risk management. We then take a detailed look at the medical software life cycle, starting with identifying user needs, mapping these to system requirements and then the process of software design, coding, testing and validation. We continue by exploring issues related to the use of machine learning techniques in medical applications from both a software engineering and a regulatory perspective. We conclude with a discussion of the business and management issues in this area focusing on the impact on digital health on modern healthcare and issues related to starting new ventures. This is a class aimed at either third- or fourth-year undergraduates in computer science, biomedical engineering, and related fields, and to junior software engineers currently either working in, or interested in moving to, the medical device industry.

Course Content

Introduction to Medical Software

A Message from the Professor
001 01_getting-started_instructions.html

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004 02_introduction-to-this-class.mp4

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007 03_a-guided-tour-of-medical-software.mp4

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010 04_a-guided-tour-of-medical-software-2.mp4

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013 01_medical-devices-and-the-regulatory-process.mp4

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015 02_u-s-food-and-drug-administration-fda-general-wellness-policy-for-low-risk_instructions.html

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018 01_u-s-healthcare-landscape-overview.mp4

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021 02_why-is-healthcare-so-expensive.mp4

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024 03_promise-of-the-digital-transformation-of-healthcare.mp4

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025 04_national-health-expenditure-accounts_instructions.html

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026 05_us-healthcare-from-a-global-perspective-2019_instructions.html

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030 01_the-fda-mission-and-history.mp4

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031 02_promoting-safe-and-effective-drugs-for-100-years_instructions.html

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032 03_the-dalkon-shield-disaster_instructions.html

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035 04_the-quality-system-regulation.mp4

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037 05_fda-quality-system-regulation_instructions.html

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040 06_general-principles-of-software-validation.mp4

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042 07_fda-general-principles-of-software-validation_instructions.html

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045 01_the-imdrf-samd-documents.mp4

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048 02_imdrf-samd-guidance-documents_instructions.html

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053 03_the-regulatory-process.mp4

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056 04_emerging-issues-ai-ml.mp4

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058 05_fda-draft-guidance-on-ai-ml_instructions.html

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062 01_patients-doctors-and.mp4

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065 02_clinical-information-technology-it.mp4

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066 03_why-doctors-hate-their-computers-article_instructions.html

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067 04_development-of-electronic-health-record_instructions.html

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070 05_clinical-it-ii-medical-imaging.mp4

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073 06_demo-of-ehr-pacs-prof-mariam-aboian.mp4

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076 01_data-privacy.mp4

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077 02_dhss-office-of-civil-rights-guidance-regarding-methods-for-de-identification-of_index.html

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081 03_cybersecurity.mp4

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082 04_framework-for-improving-critical-infrastructure-cybersecurity_instructions.html

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084 05_principles-and-practices-for-medical-device-cybersecurity_instructions.html

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088 01_quality-management-systems.mp4

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091 02_the-imdrf-qms-guidance.mp4

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094 03_the-imdrf-qms-guidance-continued.mp4

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097 04_software-as-a-medical-device-samd-application-of-quality-management-system_instructions.html

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100 01_introduction-to-risk-management.mp4

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103 02_the-risk-management-process.mp4

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106 03_the-risk-management-process-2.mp4

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108 04_imdrf-guidance-on-risk-categorization_instructions.html

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113 01_life-cycles-and-iec-62304.mp4

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116 02_life-cycles-and-iec-62304-2.mp4

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117 03_software-life-cycles_instructions.html

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119 04_case-study-of-the-use-of-agile-techniques-in-medical-software_instructions.html

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122 01_the-igns-example-project.mp4

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123 02_image-guided-surgery_instructions.html

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124 03_from-medical-image-computing-to-computer-aided-intervention_instructions.html

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127 04_a-guided-tour-of-the-life-cycle-process.mp4

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130 05_information-transmission.mp4

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134 01_identifying-user-needs.mp4

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137 02_identifying-user-needs-continued.mp4

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140 03_user-needs-for-example-project.mp4

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143 01_systems-requirement-specification-srs.mp4

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146 02_srs-template.mp4

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149 03_srs-for-our-igns-project.mp4

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150 04_don-t-fire-the-architect-where-were-the-requirements_instructions.html

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154 01_the-software-design-document.mp4

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157 02_a-template-for-the-software-design-document.mp4

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160 03_example-software-design-for-our-igns-project.mp4

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163 01_usability-engineering.mp4

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165 02_applying-human-factors-and-usability-engineering-to-medical-devices-guidance-for_instructions.html

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167 03_human-factors-and-usability-engineering-guidance-for-medical-devices-including_instructions.html

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170 01_impact-and-analysis-emerging-digital-behavioral-health-industry.mp4

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171 02_behavioral-health-landscape_instructions.html

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173 03_digital-behavioral-health-funding_instructions.html

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177 01_construction.mp4

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180 02_managing-code-and-revision-control-systems.mp4

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183 01_introduction-to-software-testing.mp4

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186 02_integration-testing-in-realtime-fmri.mp4

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189 03_verification-and-testing.mp4

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190 04_a-graphics-processing-unit-accelerated-motion-correction-algorithm-and-modular_instructions.html

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194 01_introduction-to-probability.mp4

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197 02_multiple-events.mp4

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200 01_introduction-to-statistics.mp4

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203 02_estimating-probability-density-functions.mp4

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206 01_signal-detection.mp4

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207 02_receiver-operating-characteristic-curves_instructions.html

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210 01_statistical-significance.mp4

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213 02_statistical-significance-2.mp4

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216 03_importance-of-randomization.mp4

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217 04_the-guinness-brewer-who-revolutionized-statistics_instructions.html

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221 01_introduction-to-validation.mp4

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223 02_software-as-medical-device-samd-clinical-evaluation-guidance-for-industry-and_instructions.html

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226 03_introduction-to-clinical-trials.mp4

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228 04_declaration-of-helsinki-ethical-principles-for-medical-research-involving-human_instructions.html

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229 05_practical-tips-for-surgical-research-research-questions-hypotheses-and_instructions.html

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232 06_creating-a-validation-plan.mp4

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235 01_deployment.mp4

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238 02_maintenance-retirement.mp4

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242 01_introduction-to-ai-ml.mp4

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245 02_evaluation-of-ml-methods-and-related-issues.mp4

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248 03_introduction-to-deep-learning-prof-nicha-dvornek.mp4

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249 04_deep-learning-review-paper_instructions.html

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250 05_a-guide-to-deep-learning-in-healthcare_instructions.html

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253 01_regulatory-guidance-on-ai-ml.mp4

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255 02_a-survey-on-explainable-artificial-intelligence-xai-towards-medical-xai_instructions.html

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256 03_perspectives-and-good-practices-for-ai-and-continuously-learning-systems-in_instructions.html

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259 04_the-singapore-guidance-and-ai-ml.mp4

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260 05_singapore-guidance-on-medical-software_instructions.html

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264 06_ai-ml-and-the-software-life-cycle-prof-john-onofrey.mp4

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266 07_intriguing-properties-of-neural-networks_instructions.html

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267 08_generalizable-multi-site-training-and-testing-of-deep-neural-networks-using_instructions.html

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271 01_value-drivers-in-digital-medicine.mp4

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274 02_changing-business-models-in-healthcare.mp4

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275 03_funding-for-digital-health-skyrockets-article_instructions.html

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276 04_drivers-of-digital-health-growth_instructions.html

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277 05_future-of-digital-health-drivers_instructions.html

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278 06_fda-what-is-digital-health_instructions.html

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279 07_fda-guidance-documents-that-relate-to-digital-health_instructions.html

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282 01_setting-up-a-new-healthcare-venture.mp4

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285 02_finding-your-first-paying-customer.mp4

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288 03_when-and-how-to-raise-capital.mp4

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289 04_resources-for-digital-health-venture-funding_instructions.html

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290 05_summary-of-digital-health-ventures-financing_instructions.html

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293 01_therac-25-presented-by-anmei-little.mp4

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294 02_an-investigation-of-the-therac-25-accidents_instructions.html

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296 03_fatal-dose-radiation-deaths-linked-to-aecl-computer-errors_fatal_dose.html

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300 01_healthcare-gov-presented-by-daisha-roberts.mp4

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301 02_link-to-the-full-segment-from-nbc-news-coverage-of-the-launch-of-healthcare-gov_instructions.html

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302 03_health-and-human-services-investigation_instructions.html

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306 01_iowa-2020-caucus-app-presented-by-alex-chen.mp4

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307 02_link-to-the-full-segment-from-msnbc-s-coverage-of-the-iowa-democratic-party_instructions.html

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308 03_iowas-tally-by-app-experiment-fails_instructions.html

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309 04_heres-the-shadow-inc-app-that-failed-in-iowa-last-night_instructions.html

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312 01_wannacry-and-the-uk-nhs-presented-by-ellie-gabriel.mp4

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313 02_link-to-the-bbc-news-segment-used-as-part-of-the-presentation_instructions.html

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314 03_uk-nhs-investigation-report_instructions.html

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316 01_descriptions-and-links-to-the-complete-videos-on-youtube_instructions.html

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links.txt

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About Course

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Course Content

Introduction to Medical Software

A Message from the Professor

001 01_getting-started_instructions.html

004 02_introduction-to-this-class.mp4

007 03_a-guided-tour-of-medical-software.mp4

010 04_a-guided-tour-of-medical-software-2.mp4

013 01_medical-devices-and-the-regulatory-process.mp4

015 02_u-s-food-and-drug-administration-fda-general-wellness-policy-for-low-risk_instructions.html

018 01_u-s-healthcare-landscape-overview.mp4

021 02_why-is-healthcare-so-expensive.mp4

024 03_promise-of-the-digital-transformation-of-healthcare.mp4

025 04_national-health-expenditure-accounts_instructions.html

026 05_us-healthcare-from-a-global-perspective-2019_instructions.html

030 01_the-fda-mission-and-history.mp4

031 02_promoting-safe-and-effective-drugs-for-100-years_instructions.html

032 03_the-dalkon-shield-disaster_instructions.html

035 04_the-quality-system-regulation.mp4

037 05_fda-quality-system-regulation_instructions.html

040 06_general-principles-of-software-validation.mp4

042 07_fda-general-principles-of-software-validation_instructions.html

045 01_the-imdrf-samd-documents.mp4

048 02_imdrf-samd-guidance-documents_instructions.html

053 03_the-regulatory-process.mp4

056 04_emerging-issues-ai-ml.mp4

058 05_fda-draft-guidance-on-ai-ml_instructions.html

062 01_patients-doctors-and.mp4

065 02_clinical-information-technology-it.mp4

066 03_why-doctors-hate-their-computers-article_instructions.html

067 04_development-of-electronic-health-record_instructions.html

070 05_clinical-it-ii-medical-imaging.mp4

073 06_demo-of-ehr-pacs-prof-mariam-aboian.mp4

076 01_data-privacy.mp4

077 02_dhss-office-of-civil-rights-guidance-regarding-methods-for-de-identification-of_index.html

081 03_cybersecurity.mp4

082 04_framework-for-improving-critical-infrastructure-cybersecurity_instructions.html

084 05_principles-and-practices-for-medical-device-cybersecurity_instructions.html

088 01_quality-management-systems.mp4

091 02_the-imdrf-qms-guidance.mp4

094 03_the-imdrf-qms-guidance-continued.mp4

097 04_software-as-a-medical-device-samd-application-of-quality-management-system_instructions.html

100 01_introduction-to-risk-management.mp4

103 02_the-risk-management-process.mp4

106 03_the-risk-management-process-2.mp4

108 04_imdrf-guidance-on-risk-categorization_instructions.html

113 01_life-cycles-and-iec-62304.mp4

116 02_life-cycles-and-iec-62304-2.mp4

117 03_software-life-cycles_instructions.html

119 04_case-study-of-the-use-of-agile-techniques-in-medical-software_instructions.html

122 01_the-igns-example-project.mp4

123 02_image-guided-surgery_instructions.html

124 03_from-medical-image-computing-to-computer-aided-intervention_instructions.html

127 04_a-guided-tour-of-the-life-cycle-process.mp4

130 05_information-transmission.mp4

134 01_identifying-user-needs.mp4

137 02_identifying-user-needs-continued.mp4

140 03_user-needs-for-example-project.mp4

143 01_systems-requirement-specification-srs.mp4

146 02_srs-template.mp4

149 03_srs-for-our-igns-project.mp4

150 04_don-t-fire-the-architect-where-were-the-requirements_instructions.html

154 01_the-software-design-document.mp4

157 02_a-template-for-the-software-design-document.mp4

160 03_example-software-design-for-our-igns-project.mp4

163 01_usability-engineering.mp4

165 02_applying-human-factors-and-usability-engineering-to-medical-devices-guidance-for_instructions.html

167 03_human-factors-and-usability-engineering-guidance-for-medical-devices-including_instructions.html

170 01_impact-and-analysis-emerging-digital-behavioral-health-industry.mp4

171 02_behavioral-health-landscape_instructions.html

173 03_digital-behavioral-health-funding_instructions.html

177 01_construction.mp4

180 02_managing-code-and-revision-control-systems.mp4

183 01_introduction-to-software-testing.mp4

186 02_integration-testing-in-realtime-fmri.mp4

189 03_verification-and-testing.mp4

190 04_a-graphics-processing-unit-accelerated-motion-correction-algorithm-and-modular_instructions.html

194 01_introduction-to-probability.mp4

197 02_multiple-events.mp4