Medical Device Software Compliance Essentials Course Curriculum
This comprehensive course is designed to provide participants with a thorough understanding of the regulatory requirements and industry standards for medical device software compliance. Upon completion, participants will receive a Certificate of Completion issued by The Art of Service.Course Overview This course is structured into 8 modules, covering over 80 topics, to ensure that participants gain a deep understanding of the complex regulatory landscape surrounding medical device software. The course is designed to be interactive, engaging, and practical, with real-world applications and hands-on projects.
Course Outline Module 1: Introduction to Medical Device Software Compliance
- Overview of medical device software regulations
- Understanding the role of regulatory bodies (FDA, EU, etc.)
- Introduction to industry standards (IEC 62304, ISO 13485, etc.)
- Importance of compliance in medical device software development
- Case studies: real-world examples of non-compliance
Module 2: Regulatory Framework for Medical Device Software
- In-depth analysis of FDA regulations (21 CFR Part 820, etc.)
- EU MDR and IVDR regulations for medical device software
- Understanding the differences between FDA and EU regulations
- Role of guidance documents (FDA guidance, EU guidance, etc.)
- Impact of regulatory changes on medical device software development
Module 3: Software Development Life Cycle (SDLC)
- Overview of the SDLC process
- Requirements gathering and analysis
- Design and development of medical device software
- Testing and validation strategies
- Release and deployment processes
- Maintenance and post-market surveillance
Module 4: Risk Management for Medical Device Software
- Introduction to risk management principles
- ISO 14971: Application of risk management to medical devices
- Risk assessment and analysis techniques
- Risk control measures and mitigation strategies
- Case studies: risk management in medical device software development
Module 5: Software Verification and Validation
- Principles of software verification and validation
- Types of testing: unit testing, integration testing, etc.
- Test planning and execution
- Defect tracking and resolution
- Validation of software requirements
- Case studies: software verification and validation in medical device software development
Module 6: Quality Management System (QMS) for Medical Device Software
- Overview of QMS principles
- ISO 13485: Medical devices - Quality management systems
- QMS requirements for medical device software development
- Documentation and record-keeping requirements
- Auditing and compliance strategies
Module 7: Cybersecurity for Medical Device Software
- Introduction to cybersecurity principles
- Cybersecurity risks in medical device software
- Risk assessment and mitigation strategies
- Cybersecurity testing and validation
- Post-market cybersecurity monitoring and maintenance
Module 8: Compliance Strategies and Best Practices
- Strategies for achieving and maintaining compliance
- Best practices for medical device software development
- Case studies: successful compliance strategies
- Common pitfalls and lessons learned
- Future trends and emerging issues in medical device software compliance
Course Features - Interactive and engaging content: videos, animations, and gamification
- Comprehensive and up-to-date content: covering the latest regulations and industry standards
- Practical and real-world applications: case studies and hands-on projects
- Expert instructors: experienced professionals in medical device software compliance
- Certificate of Completion: issued by The Art of Service upon completion
- Flexible learning: self-paced online learning with lifetime access
- User-friendly and mobile-accessible: accessible on multiple devices
- Community-driven: discussion forums and peer-to-peer learning
- Actionable insights: practical takeaways and implementation strategies
- Hands-on projects: applying concepts to real-world scenarios
- Bite-sized lessons: concise and focused learning modules
- Progress tracking: monitoring progress and achievement
- Gamification: engaging and motivating learning experience
Upon completion of this course, participants will have gained a comprehensive understanding of medical device software compliance essentials and be equipped with the knowledge and skills to implement effective compliance strategies in their organizations.,
Module 1: Introduction to Medical Device Software Compliance
- Overview of medical device software regulations
- Understanding the role of regulatory bodies (FDA, EU, etc.)
- Introduction to industry standards (IEC 62304, ISO 13485, etc.)
- Importance of compliance in medical device software development
- Case studies: real-world examples of non-compliance
Module 2: Regulatory Framework for Medical Device Software
- In-depth analysis of FDA regulations (21 CFR Part 820, etc.)
- EU MDR and IVDR regulations for medical device software
- Understanding the differences between FDA and EU regulations
- Role of guidance documents (FDA guidance, EU guidance, etc.)
- Impact of regulatory changes on medical device software development
Module 3: Software Development Life Cycle (SDLC)
- Overview of the SDLC process
- Requirements gathering and analysis
- Design and development of medical device software
- Testing and validation strategies
- Release and deployment processes
- Maintenance and post-market surveillance
Module 4: Risk Management for Medical Device Software
- Introduction to risk management principles
- ISO 14971: Application of risk management to medical devices
- Risk assessment and analysis techniques
- Risk control measures and mitigation strategies
- Case studies: risk management in medical device software development
Module 5: Software Verification and Validation
- Principles of software verification and validation
- Types of testing: unit testing, integration testing, etc.
- Test planning and execution
- Defect tracking and resolution
- Validation of software requirements
- Case studies: software verification and validation in medical device software development
Module 6: Quality Management System (QMS) for Medical Device Software
- Overview of QMS principles
- ISO 13485: Medical devices - Quality management systems
- QMS requirements for medical device software development
- Documentation and record-keeping requirements
- Auditing and compliance strategies
Module 7: Cybersecurity for Medical Device Software
- Introduction to cybersecurity principles
- Cybersecurity risks in medical device software
- Risk assessment and mitigation strategies
- Cybersecurity testing and validation
- Post-market cybersecurity monitoring and maintenance
Module 8: Compliance Strategies and Best Practices
- Strategies for achieving and maintaining compliance
- Best practices for medical device software development
- Case studies: successful compliance strategies
- Common pitfalls and lessons learned
- Future trends and emerging issues in medical device software compliance