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Introduction to Software for Medical Devices and IEC 62304

Learn how to be effective in medical device software development during this self paced, interactive online course.

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About this course

This online course focuses on the process of developing software for medical devices. This includes topics such as how to efficiently plan and document software development, getting requirements right, how to approach software architecture and software risk management, how to perform software safety classification correctly and working with SOUP/OTS software.

The course covers all aspects of the IEC 62304 standard and the relationship between the IEC 62304 and other standards such as ISO 14971, IEC 60601-1 and IEC 82304–1.

The course is suitable for anyone working with software development, such as R&D engineers, quality assurance department and auditors of software development. The course does not cover actual coding

Learners will have access to the online course for 6 months to review the material and pass the exam. One exam attempt is included and the score earned will be printed on the learner's certificate. 

Curriculum10 - 16 hours

  • Introduction
  • Course goals
  • Welcome
  • Introduction to software and medical devices
  • What is software and what makes it different
  • Quiz - What is software and what makes it different
  • General software terminology
  • Quiz - General software terminology
  • Introduction to the regulatory landscape
  • Quiz - Introduction to the regulatory landscape
  • Introduction to classification of medical devices and software
  • Quiz - Introduction to classification of medical devices and software
  • IEC 62304 in relation to other standards
  • Quiz - IEC 62304 in relation to other standards
  • The gap between IEC 60601-1 and IEC 62304
  • Quiz - The gap between IEC 60601-1 and IEC 62304
  • IEC 82304-1, a product standard for health software
  • Quiz - IEC 82304-1, a product standard for health softwareUntitled Section
  • Introduction to risk
  • Quiz - Introduction to risk
  • Introduction to IEC 62304
  • Scope and general terminology - Part 1
  • Scope and general terminology - Part 2
  • Quiz - Scope and general terminology
  • General requirements (IEC 62304)
  • Development process and compliance
  • Quiz - Development process and compliance
  • Software safety classification - Part 1
  • Software safety classification - Part 2
  • Software safety classification - Part 3
  • Quiz - Software safety classification
  • Legacy software
  • Quiz - Legacy software
  • Software risk management
  • Understanding software risk management
  • Quiz - Understanding software risk management
  • Development process as risk control - Part 1
  • Development process as risk control - Part 2
  • Quiz - Development process as risk control
  • Software risk management in IEC 62304 - Part 1
  • Software risk management in IEC 62304 - Part 2
  • Quiz - Software risk management in IEC 62304
  • Software causes
  • Quiz - Software causes
  • Software risk control measures
  • Quiz - Software risk control measures
  • Software planning
  • Development planning - Part 1
  • Development planning - Part 2
  • Development planning - Part 3
  • Quiz - Development planning
  • Configuration management
  • Quiz - Configuration management
  • SOUPs, how to manage and document - Part 1
  • SOUPs, how to manage and document - Part 2
  • Quiz - SOUPs, how to manage and document
  • Software design
  • Software requirements - Part 1
  • Software requirements - Part 2
  • Quiz - Software requirements
  • Software architecture - Part 1
  • Software architecture - Part 2
  • Quiz - Software architecture
  • Software detailed design
  • Quiz - Software detailed design
  • Software unit implementation
  • Quiz - Software unit implementation
  • SW testing
  • Software integration testing
  • Quiz- Software integration testing
  • Software system testing
  • Quiz - Software system testing
  • SW release and post release management
  • Software release
  • Quiz - Software release
  • Maintenance plan
  • Quiz - Maintenance plan
  • Problem resolution - the process
  • Quiz - Problem resolution - the process
  • Change control
  • Quiz - Change control
  • Final exam
  • Final exam
  • Course evaluation
  • Course evaluation

About this course

This online course focuses on the process of developing software for medical devices. This includes topics such as how to efficiently plan and document software development, getting requirements right, how to approach software architecture and software risk management, how to perform software safety classification correctly and working with SOUP/OTS software.

The course covers all aspects of the IEC 62304 standard and the relationship between the IEC 62304 and other standards such as ISO 14971, IEC 60601-1 and IEC 82304–1.

The course is suitable for anyone working with software development, such as R&D engineers, quality assurance department and auditors of software development. The course does not cover actual coding

Learners will have access to the online course for 6 months to review the material and pass the exam. One exam attempt is included and the score earned will be printed on the learner's certificate. 

Curriculum10 - 16 hours

  • Introduction
  • Course goals
  • Welcome
  • Introduction to software and medical devices
  • What is software and what makes it different
  • Quiz - What is software and what makes it different
  • General software terminology
  • Quiz - General software terminology
  • Introduction to the regulatory landscape
  • Quiz - Introduction to the regulatory landscape
  • Introduction to classification of medical devices and software
  • Quiz - Introduction to classification of medical devices and software
  • IEC 62304 in relation to other standards
  • Quiz - IEC 62304 in relation to other standards
  • The gap between IEC 60601-1 and IEC 62304
  • Quiz - The gap between IEC 60601-1 and IEC 62304
  • IEC 82304-1, a product standard for health software
  • Quiz - IEC 82304-1, a product standard for health softwareUntitled Section
  • Introduction to risk
  • Quiz - Introduction to risk
  • Introduction to IEC 62304
  • Scope and general terminology - Part 1
  • Scope and general terminology - Part 2
  • Quiz - Scope and general terminology
  • General requirements (IEC 62304)
  • Development process and compliance
  • Quiz - Development process and compliance
  • Software safety classification - Part 1
  • Software safety classification - Part 2
  • Software safety classification - Part 3
  • Quiz - Software safety classification
  • Legacy software
  • Quiz - Legacy software
  • Software risk management
  • Understanding software risk management
  • Quiz - Understanding software risk management
  • Development process as risk control - Part 1
  • Development process as risk control - Part 2
  • Quiz - Development process as risk control
  • Software risk management in IEC 62304 - Part 1
  • Software risk management in IEC 62304 - Part 2
  • Quiz - Software risk management in IEC 62304
  • Software causes
  • Quiz - Software causes
  • Software risk control measures
  • Quiz - Software risk control measures
  • Software planning
  • Development planning - Part 1
  • Development planning - Part 2
  • Development planning - Part 3
  • Quiz - Development planning
  • Configuration management
  • Quiz - Configuration management
  • SOUPs, how to manage and document - Part 1
  • SOUPs, how to manage and document - Part 2
  • Quiz - SOUPs, how to manage and document
  • Software design
  • Software requirements - Part 1
  • Software requirements - Part 2
  • Quiz - Software requirements
  • Software architecture - Part 1
  • Software architecture - Part 2
  • Quiz - Software architecture
  • Software detailed design
  • Quiz - Software detailed design
  • Software unit implementation
  • Quiz - Software unit implementation
  • SW testing
  • Software integration testing
  • Quiz- Software integration testing
  • Software system testing
  • Quiz - Software system testing
  • SW release and post release management
  • Software release
  • Quiz - Software release
  • Maintenance plan
  • Quiz - Maintenance plan
  • Problem resolution - the process
  • Quiz - Problem resolution - the process
  • Change control
  • Quiz - Change control
  • Final exam
  • Final exam
  • Course evaluation
  • Course evaluation

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