Module #1 Introduction to Regulatory Compliance Overview of regulatory compliance for medical device software, importance and benefits
Module #2 Global Regulatory Framework Overview of global regulatory frameworks for medical devices, including FDA, EU MDR, and ISO 13485
Module #3 Medical Device Classification Understanding medical device classification, including risk-based classification and device categorization
Module #4 Software as a Medical Device (SaMD) Defining SaMD, including software-based medical devices and mobile medical apps
Module #5 Regulatory Requirements for Software Development Overview of regulatory requirements for software development, including design controls and verification
Module #6 Software Risk Management Understanding software risk management, including risk analysis and mitigation strategies
Module #7 Cybersecurity for Medical Device Software Importance of cybersecurity for medical device software, including threat analysis and mitigation strategies
Module #8 FDA 21 CFR Part 11 and Annex 11 Understanding FDA 21 CFR Part 11 and Annex 11, including electronic records and signatures
Module #9 EU MDR and IVDR Software Requirements Overview of EU MDR and IVDR software requirements, including technical documentation and conformity assessment
Module #10 ISO 13485 and IEC 62304 Understanding ISO 13485 and IEC 62304, including quality management systems and software lifecycle processes
Module #11 Software Validation and Verification Understanding software validation and verification, including testing and validation protocols
Module #12 Clinical Evaluation and Clinical Trials Overview of clinical evaluation and clinical trials, including data analysis and reporting
Module #13 Regulatory Submissions and Approvals Understanding regulatory submissions and approvals, including 510(k), PMA, and CE marking
Module #14 Post-Market Surveillance and Vigilance Importance of post-market surveillance and vigilance, including adverse event reporting and recall management
Module #15 Software Change Control and Updates Understanding software change control and updates, including impact analysis and validation
Module #16 Regulatory Audits and Inspections Preparing for regulatory audits and inspections, including audit trails and documentation
Module #17 Compliance for Cloud-Based Medical Devices Understanding compliance for cloud-based medical devices, including data privacy and security
Module #18 Artificial Intelligence and Machine Learning in Medical Devices Understanding AI and ML in medical devices, including regulatory considerations and ethics
Module #19 Regulatory Compliance for Wearable Devices and Mobile Health Overview of regulatory compliance for wearable devices and mobile health, including FDA and EU guidelines
Module #20 Compliance for Software as a Service (SaaS) Medical Devices Understanding compliance for SaaS medical devices, including data protection and security
Module #21 Regulatory Compliance for Medical Device Software in Emerging Markets Overview of regulatory compliance for medical device software in emerging markets, including China, Japan, and Brazil
Module #22 Quality Management System (QMS) for Medical Device Software Understanding QMS for medical device software, including ISO 13485 and 21 CFR Part 820
Module #23 Design Controls for Medical Device Software Understanding design controls for medical device software, including design inputs, outputs, and verification
Module #24 Regulatory Compliance for Medical Device Software Updates and Patches Understanding regulatory compliance for medical device software updates and patches, including change control and validation
Module #25 Course Wrap-Up & Conclusion Planning next steps in Regulatory Compliance for Medical Device Software career
