Medical Device Software Validation
( 30 Modules )

Module #1
Introduction to Medical Device Software Validation
Overview of medical device software validation, regulatory requirements, and industry standards

Module #2
Regulatory Overview:FDA, EU, and IEC
Review of relevant regulations and standards from FDA, EU, and IEC that impact medical device software validation

Module #3
Software Development Life Cycle (SDLC) and Validation
Understanding the SDLC and how it relates to software validation, including requirements gathering, design, testing, and deployment

Module #4
Risk Management for Medical Device Software
Applying risk management principles to medical device software, including risk analysis, mitigation, and control

Module #5
Software Requirements Specification (SRS) and Validation
Creating and validating software requirements specifications, including verification and validation techniques

Module #6
Design Controls for Medical Device Software
Applying design controls to medical device software, including design inputs, outputs, and verification

Module #7
Software Verification and Validation (V&V) Planning
Developing a V&V plan, including test planning, test cases, and test data

Module #8
Unit Testing and Integration Testing
Best practices for unit testing and integration testing of medical device software

Module #9
System Testing and System Integration Testing
Approaches to system testing and system integration testing, including test environment setup and test execution

Module #10
Validation of Off-the-Shelf (OTS) Software
Challenges and strategies for validating OTS software used in medical devices

Module #11
Software Configuration Management (SCM) and Change Control
Best practices for SCM and change control, including versioning, branching, and baselining

Module #12
Software Documentation and Record-Keeping
Importance of documentation and record-keeping for medical device software validation, including documentation types and standards

Module #13
Software Validation Reporting and Metrics
Creating effective validation reports, including metrics, dashboards, and key performance indicators (KPIs)

Module #14
FDA 510(k) and CE Marking Submissions for Software
Preparing and submitting regulatory filings for medical device software, including FDA 510(k) and CE Marking

Module #15
Audits and Inspections for Medical Device Software
Preparing for and responding to audits and inspections, including internal audits, regulatory audits, and supplier audits

Module #16
Software Maintenance and Updates
Managing software maintenance and updates, including impact analysis, testing, and validation

Module #17
Cybersecurity for Medical Device Software
Addressing cybersecurity risks and threats in medical device software, including threat modeling and vulnerability management

Module #18
Cloud-Based Medical Device Software Validation
Unique challenges and considerations for validating cloud-based medical device software

Module #19
Artificial Intelligence (AI) and Machine Learning (ML) in Medical Devices
Validation considerations for AI and ML in medical devices, including data quality, model validation, and bias mitigation

Module #20
Medical Device Software Validation for Mobile Devices
Unique considerations for validating medical device software on mobile devices, including mobile operating systems and connectivity

Module #21
Medical Device Software Validation for Wearables and IoT
Challenges and strategies for validating medical device software on wearables and IoT devices

Module #22
Validation of Medical Device Software for Clinical Trials
Unique considerations for validating medical device software used in clinical trials, including data quality and integrity

Module #23
Lessons Learned from Real-World Validation Projects
Case studies and lessons learned from real-world medical device software validation projects

Module #24
Trends and Future Directions in Medical Device Software Validation
Emerging trends and future directions in medical device software validation, including AI, ML, and cloud computing

Module #25
Best Practices for Medical Device Software Validation
Best practices and tips for successful medical device software validation, including resource allocation and project planning

Module #26
Effective Communication in Medical Device Software Validation
Importance of effective communication in medical device software validation, including stakeholder management and team collaboration

Module #27
Medical Device Software Validation for Startups and Small Businesses
Unique challenges and considerations for startups and small businesses implementing medical device software validation

Module #28
Medical Device Software Validation for Global Markets
Challenges and strategies for validating medical device software for global markets, including international regulations and standards

Module #29
Medical Device Software Validation for Legacy Systems
Unique considerations for validating medical device software on legacy systems, including upgrade and migration strategies

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Medical Device Software Validation career

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Medical Device Software Validation ( 30 Modules )

Medical Device Software Validation
( 30 Modules )