Regulatory Compliance in Biomedical Software Development
( 30 Modules )

Module #1
Introduction to Regulatory Compliance
Overview of regulatory compliance in biomedical software development, importance, and consequences of non-compliance

Module #2
Regulatory Frameworks and Standards
Overview of relevant regulatory frameworks and standards (e.g. FDA, CE, IEC, ISO)

Module #3
Medical Device Regulations
In-depth look at medical device regulations (e.g. FDA 21 CFR 820, EU MDR)

Module #4
Software as a Medical Device (SaMD)
Regulatory considerations for software as a medical device (SaMD)

Module #5
Risk Management in Biomedical Software Development
Risk management principles and practices for biomedical software development

Module #6
Quality Management Systems (QMS)
Overview of QMS principles and practices (e.g. ISO 13485, FDA 21 CFR 820)

Module #7
Design Controls and Design Verification
Design controls and design verification principles and practices for biomedical software development

Module #8
Software Development Life Cycle (SDLC) and Agile
Applying SDLC principles and Agile methodologies to biomedical software development

Module #9
Testing and Validation
Software testing and validation principles and practices for biomedical software development

Module #10
Documentation and Record-Keeping
Documentation and record-keeping requirements and best practices for biomedical software development

Module #11
Change Control and Configuration Management
Change control and configuration management principles and practices for biomedical software development

Module #12
Supplier Management and Outsourcing
Regulatory considerations for supplier management and outsourcing in biomedical software development

Module #13
Cybersecurity and Data Privacy
Regulatory considerations for cybersecurity and data privacy in biomedical software development

Module #14
Clinical Evaluation and Clinical Trials
Clinical evaluation and clinical trial principles and practices for biomedical software development

Module #15
Regulatory Submissions and Approvals
Regulatory submission and approval processes for biomedical software development

Module #16
Post-Market Surveillance and Vigilance
Post-market surveillance and vigilance principles and practices for biomedical software development

Module #17
Audits and Inspections
Preparing for and responding to audits and inspections in biomedical software development

Module #18
Regulatory Compliance for Specific Industries
Regulatory compliance considerations for specific industries (e.g. medical imaging, IVD, orthopedic)

Module #19
Global Regulatory Considerations
Regulatory considerations for global markets (e.g. EU, US, Canada, China)

Module #20
Regulatory Compliance Tools and Resources
Overview of regulatory compliance tools and resources (e.g. software, templates, consulting services)

Module #21
Training and Competency
Training and competency requirements for personnel involved in biomedical software development

Module #22
Continuous Improvement and Quality Metrics
Continuous improvement and quality metrics principles and practices for biomedical software development

Module #23
Regulatory Compliance for Startups and Small Companies
Regulatory compliance considerations for startups and small companies in biomedical software development

Module #24
Regulatory Compliance for Cloud-Based Solutions
Regulatory compliance considerations for cloud-based biomedical software solutions

Module #25
Regulatory Compliance for Artificial Intelligence and Machine Learning
Regulatory compliance considerations for AI and ML in biomedical software development

Module #26
Regulatory Compliance for Mobile Medical Apps
Regulatory compliance considerations for mobile medical apps

Module #27
Regulatory Compliance for Wearables and IoT Devices
Regulatory compliance considerations for wearables and IoT devices in biomedical software development

Module #28
Regulatory Compliance for Telemedicine and Remote Patient Monitoring
Regulatory compliance considerations for telemedicine and remote patient monitoring

Module #29
Regulatory Compliance for Data Analytics and Big Data
Regulatory compliance considerations for data analytics and big data in biomedical software development

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Compliance in Biomedical Software Development career

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Regulatory Compliance in Biomedical Software Development ( 30 Modules )

Regulatory Compliance in Biomedical Software Development
( 30 Modules )