Introduction to Project Management for Product Development of Medical Devices

This is a online course that provides a high-level overview as well as hands-on tools and techniques for developing a medical device within budget and schedule constraints. It is a pre-requisite to have good knowledge and experience of design control before starting the course. We also strongly recommend that you take the Introduction to Design Control for Medical Devices online course before this course.

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About this course

This is an online course that provides a high-level overview as well as hands-on tools and techniques for developing a medical device within budget and schedule constraints. It is a prerequisite to have good knowledge and experience of design control before starting the course.
We also strongly recommend that you take the Introduction to Design Control for Medical Devices online course before this course.

This course will guide you through the process from invention or market brief, through pre-studies, to product approval and everything in between, preparing you to lead or take part in that process yourself. This course talks about pitfalls, challenges, and issues that many medical device projects face, and not least, how to avoid them. This will prepare you and make you ready to combat a lot of difficult situations in your work-life.

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. 

 

Curriculum15 - 20 hours

  • Introduction
  • Course goals
  • Welcome
  • The medical device project context
  • The medical device world
  • The project process - Part 1
  • The project process - Part 2
  • Quiz - The project process
  • Medical device project processes
  • Quiz - Medical device project processes
  • Introduction to project management
  • Projects and project management
  • Quiz - Projects and project management
  • The project organisation
  • Quiz - The project organisation
  • The project manager and the stakeholders
  • Quiz - The project manager and the stakeholders
  • The project priorities
  • Quiz - The project priorities
  • Getting the project started
  • The course outline and tools and techniques
  • Quiz - The course outline and tools and techniques
  • Develop a project charter
  • Quiz - Develop a project charter
  • The project charter paradox
  • Quiz - The project charter paradox
  • Project success
  • Quiz - Project success
  • Plan stakeholder engagement
  • Quiz - Plan stakeholder engagement
  • Planning - Scope
  • Planning a project
  • Quiz - Planning a project
  • Collect requirements - Part 1
  • Collect requirements - Part 2
  • Quiz - Collect requirements
  • Define scope - Part 1
  • Define scope - Part 2
  • Quiz - Define scope
  • Verification and validation planning
  • Quiz - Verification and validation planning
  • Create WBS
  • Quiz - Create WBS
  • Baselines
  • Quiz - Baselines
  • Planning - Project risk management
  • Project risk management - Part 1
  • Project risk management - Part 2
  • Quiz - Project risk management
  • Reserve time and project risk profile - Part 1
  • Reserve time and project risk profile - Part 2
  • Planning - Schedule
  • Create a schedule - Part 1
  • Create a schedule - Part 2
  • Quiz - Create a schedule
  • Optimising your schedule
  • Quiz - Optimising your schedule
  • Using and visualising your schedule
  • The probability in scheduling
  • Quiz - The probability in scheduling
  • The critical chain
  • Medical device scheduling - Part 1
  • Medical device scheduling - Part 2
  • Planning human resources
  • Develop the human resource plan
  • Quiz - Develop the human resource plan
  • Create the project budget
  • Project budget and risk - Part 1
  • Project budget and risk - Part 2
  • Quiz - Project budget and risk
  • Create the project plan
  • Create the project plan
  • Quiz - Create the project plan
  • Project execution
  • Direct and manage project work (Design)
  • Controlling schedule and cost
  • Quiz - Controlling schedule and cost
  • Control scope
  • Quiz - Control scope
  • Earned value management and forecasting
  • Quiz - Earned value management and forecasting
  • Project close-out
  • Project close-out
  • Quiz - Project close-out
  • Final exam
  • Final exam - Project management
  • Course evaluation
  • Course evaluation - Project management

About this course

This is an online course that provides a high-level overview as well as hands-on tools and techniques for developing a medical device within budget and schedule constraints. It is a prerequisite to have good knowledge and experience of design control before starting the course.
We also strongly recommend that you take the Introduction to Design Control for Medical Devices online course before this course.

This course will guide you through the process from invention or market brief, through pre-studies, to product approval and everything in between, preparing you to lead or take part in that process yourself. This course talks about pitfalls, challenges, and issues that many medical device projects face, and not least, how to avoid them. This will prepare you and make you ready to combat a lot of difficult situations in your work-life.

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. 

 

Curriculum15 - 20 hours

  • Introduction
  • Course goals
  • Welcome
  • The medical device project context
  • The medical device world
  • The project process - Part 1
  • The project process - Part 2
  • Quiz - The project process
  • Medical device project processes
  • Quiz - Medical device project processes
  • Introduction to project management
  • Projects and project management
  • Quiz - Projects and project management
  • The project organisation
  • Quiz - The project organisation
  • The project manager and the stakeholders
  • Quiz - The project manager and the stakeholders
  • The project priorities
  • Quiz - The project priorities
  • Getting the project started
  • The course outline and tools and techniques
  • Quiz - The course outline and tools and techniques
  • Develop a project charter
  • Quiz - Develop a project charter
  • The project charter paradox
  • Quiz - The project charter paradox
  • Project success
  • Quiz - Project success
  • Plan stakeholder engagement
  • Quiz - Plan stakeholder engagement
  • Planning - Scope
  • Planning a project
  • Quiz - Planning a project
  • Collect requirements - Part 1
  • Collect requirements - Part 2
  • Quiz - Collect requirements
  • Define scope - Part 1
  • Define scope - Part 2
  • Quiz - Define scope
  • Verification and validation planning
  • Quiz - Verification and validation planning
  • Create WBS
  • Quiz - Create WBS
  • Baselines
  • Quiz - Baselines
  • Planning - Project risk management
  • Project risk management - Part 1
  • Project risk management - Part 2
  • Quiz - Project risk management
  • Reserve time and project risk profile - Part 1
  • Reserve time and project risk profile - Part 2
  • Planning - Schedule
  • Create a schedule - Part 1
  • Create a schedule - Part 2
  • Quiz - Create a schedule
  • Optimising your schedule
  • Quiz - Optimising your schedule
  • Using and visualising your schedule
  • The probability in scheduling
  • Quiz - The probability in scheduling
  • The critical chain
  • Medical device scheduling - Part 1
  • Medical device scheduling - Part 2
  • Planning human resources
  • Develop the human resource plan
  • Quiz - Develop the human resource plan
  • Create the project budget
  • Project budget and risk - Part 1
  • Project budget and risk - Part 2
  • Quiz - Project budget and risk
  • Create the project plan
  • Create the project plan
  • Quiz - Create the project plan
  • Project execution
  • Direct and manage project work (Design)
  • Controlling schedule and cost
  • Quiz - Controlling schedule and cost
  • Control scope
  • Quiz - Control scope
  • Earned value management and forecasting
  • Quiz - Earned value management and forecasting
  • Project close-out
  • Project close-out
  • Quiz - Project close-out
  • Final exam
  • Final exam - Project management
  • Course evaluation
  • Course evaluation - Project management

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