Software Validation and Verification for Medical Devices
( 30 Modules )

Module #1
Introduction to Software Validation and Verification for Medical Devices
Overview of the importance and regulatory requirements for software validation and verification in medical devices

Module #2
Medical Device Regulations and Standards
Review of relevant regulations, standards, and guidelines, including FDA, IEC 62304, and ISO 13485

Module #3
Software Development Life Cycle for Medical Devices
Understanding the software development process and its application to medical devices

Module #4
Risk Management for Medical Device Software
Introduction to risk management principles and their application to medical device software

Module #5
Software Validation and Verification:Definitions and Concepts
Understanding the differences and relationships between software validation and verification

Module #6
Software Verification Planning
Creating a verification plan and strategy for medical device software

Module #7
Software Verification Methods and Techniques
Overview of verification methods, including unit testing, integration testing, and system testing

Module #8
Verification of Medical Device Software Requirements
Verifying software requirements, including functional, performance, and safety requirements

Module #9
Verification of Medical Device Software Design
Verifying software design, including architecture, component design, and interface design

Module #10
Verification of Medical Device Software Implementation
Verifying software implementation, including code reviews, unit testing, and integration testing

Module #11
Software Validation Planning
Creating a validation plan and strategy for medical device software

Module #12
Software Validation Methods and Techniques
Overview of validation methods, including black box, white box, and gray box testing

Module #13
Validation of Medical Device Software Requirements
Validating software requirements, including functional, performance, and safety requirements

Module #14
Validation of Medical Device Software Design
Validating software design, including architecture, component design, and interface design

Module #15
Validation of Medical Device Software Implementation
Validating software implementation, including system testing, usability testing, and performance testing

Module #16
Agile and Iterative Development for Medical Device Software
Applying agile and iterative development methodologies to medical device software

Module #17
Cloud-Based and Connected Medical Devices
Unique considerations for software validation and verification of cloud-based and connected medical devices

Module #18
Machine Learning and AI in Medical Devices
Special considerations for software validation and verification of medical devices with machine learning and AI components

Module #19
Cybersecurity for Medical Device Software
Understanding the importance of cybersecurity in medical device software and its impact on validation and verification

Module #20
Continuous Integration and Continuous Deployment for Medical Device Software
Applying DevOps principles to medical device software development and validation

Module #21
FDA Regulations and Guidance for Medical Device Software
In-depth review of FDA regulations and guidance for medical device software

Module #22
EU MDR and IVDR Regulations for Medical Device Software
Overview of EU MDR and IVDR regulations and their impact on medical device software

Module #23
ISO 13485 and IEC 62304 for Medical Device Software
Understanding the application of ISO 13485 and IEC 62304 to medical device software

Module #24
Compliance and Regulatory Audits for Medical Device Software
Preparing for and navigating compliance and regulatory audits for medical device software

Module #25
Post-Market Surveillance and Vigilance for Medical Device Software
Understanding post-market surveillance and vigilance requirements for medical device software

Module #26
Implementing Software Validation and Verification in a Medical Device Company
Practical considerations for implementing software validation and verification in a medical device company

Module #27
Best Practices for Software Validation and Verification of Medical Devices
Industry best practices for software validation and verification of medical devices

Module #28
Collaboration and Communication between Software and Regulatory Teams
Improving collaboration and communication between software development and regulatory teams

Module #29
Software Validation and Verification Project Management
Managing software validation and verification projects effectively

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Software Validation and Verification for Medical Devices career

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Software Validation and Verification for Medical Devices ( 30 Modules )

Software Validation and Verification for Medical Devices
( 30 Modules )