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Introduction to Design Control for Medical Devices

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

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About this course

This online course focuses on understanding the process of how to develop new medical devices and maintaining them in organisations where design control requirements apply.

The course mentions both European and US requirements and introduces tools on how to work successfully and efficiently with design control.

We recommend this course for those who are new in the field as well as professionals involved in the development of medical devices such as quality assurance, project management, design engineering or those involved in R&D and product development teams.
 
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. 

Curriculum8 - 16 hours

  • Introduction
  • Course goals
  • Welcome
  • Why design control and what is it?
  • Quiz - Why design control and what is it?
  • Agile, waterfall, project management and design control
  • Quiz - Agile, waterfall, project management and design control
  • What is a medical device?
  • Quiz - What is a medical device?
  • The changing regulatory landscape
  • Quiz - The changing regulatory landscape
  • The project process
  • Speaking design controlish
  • Quiz - Speaking design controlish
  • Product documentation
  • Quiz - Product documentation
  • The project process - Part 1
  • The project process - Part 2
  • Quiz - The project process
  • Where do all the requirements come from
  • Why document so much?
  • The most essential requirements
  • Quiz - The most essential requirements
  • Standards and guidance documents
  • Why standards
  • Quiz - Why standards
  • The names and numbers of standards
  • Quiz - The names and numbers of standards
  • Areas covered by standards
  • Quiz - Areas covered by standards
  • Product approval and classification
  • Medical device product classification
  • Quiz - Medical device product classification
  • Product approval
  • Quiz - Product approval
  • Design and development inputs
  • User needs and design input
  • Quiz - User needs and design input
  • The V model and requirement traceability
  • Quiz - The V model and requirement traceability
  • How to write requirements
  • Quiz - How to write requirements
  • How to manage requirements - Part 1
  • How to manage requirements - Part 2
  • Quiz - How to manage requirements
  • Risk management
  • Introduction to risk management
  • Quiz - Introduction to risk management
  • Usability engineering
  • Usability engineering
  • Quiz - Usability engineering
  • Design planning
  • Why planning?
  • Quiz - Why planning?
  • The design and project plans
  • Quiz - The design and project plans
  • Other plans and requirements
  • Quiz - Other plans and requirements
  • Design Review
  • Design review
  • Quiz - Design review
  • Phase and design outputs
  • Design and design output
  • Quiz - Design and design output
  • Process and product requirements
  • Quiz - Process and product requirements
  • Design transfer
  • What is design transfer?
  • Quiz - What is design transfer?
  • Process validation
  • Quiz - Process validation
  • Design verification and validation
  • From design input to end
  • Before you start verification
  • Quiz - Before you start verification
  • Methods and validation
  • Quiz - Methods and validation
  • Change control
  • Change control
  • Quiz - Change control
  • How it all fits together
  • How it all fits together - Part 1
  • How it all fits together - Part 2
  • Quiz - How it all fits together
  • Final exam
  • Final Exam - Design control
  • Course evaluation
  • Course evaluation
  • Conclusion

About this course

This online course focuses on understanding the process of how to develop new medical devices and maintaining them in organisations where design control requirements apply.

The course mentions both European and US requirements and introduces tools on how to work successfully and efficiently with design control.

We recommend this course for those who are new in the field as well as professionals involved in the development of medical devices such as quality assurance, project management, design engineering or those involved in R&D and product development teams.
 
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. 

Curriculum8 - 16 hours

  • Introduction
  • Course goals
  • Welcome
  • Why design control and what is it?
  • Quiz - Why design control and what is it?
  • Agile, waterfall, project management and design control
  • Quiz - Agile, waterfall, project management and design control
  • What is a medical device?
  • Quiz - What is a medical device?
  • The changing regulatory landscape
  • Quiz - The changing regulatory landscape
  • The project process
  • Speaking design controlish
  • Quiz - Speaking design controlish
  • Product documentation
  • Quiz - Product documentation
  • The project process - Part 1
  • The project process - Part 2
  • Quiz - The project process
  • Where do all the requirements come from
  • Why document so much?
  • The most essential requirements
  • Quiz - The most essential requirements
  • Standards and guidance documents
  • Why standards
  • Quiz - Why standards
  • The names and numbers of standards
  • Quiz - The names and numbers of standards
  • Areas covered by standards
  • Quiz - Areas covered by standards
  • Product approval and classification
  • Medical device product classification
  • Quiz - Medical device product classification
  • Product approval
  • Quiz - Product approval
  • Design and development inputs
  • User needs and design input
  • Quiz - User needs and design input
  • The V model and requirement traceability
  • Quiz - The V model and requirement traceability
  • How to write requirements
  • Quiz - How to write requirements
  • How to manage requirements - Part 1
  • How to manage requirements - Part 2
  • Quiz - How to manage requirements
  • Risk management
  • Introduction to risk management
  • Quiz - Introduction to risk management
  • Usability engineering
  • Usability engineering
  • Quiz - Usability engineering
  • Design planning
  • Why planning?
  • Quiz - Why planning?
  • The design and project plans
  • Quiz - The design and project plans
  • Other plans and requirements
  • Quiz - Other plans and requirements
  • Design Review
  • Design review
  • Quiz - Design review
  • Phase and design outputs
  • Design and design output
  • Quiz - Design and design output
  • Process and product requirements
  • Quiz - Process and product requirements
  • Design transfer
  • What is design transfer?
  • Quiz - What is design transfer?
  • Process validation
  • Quiz - Process validation
  • Design verification and validation
  • From design input to end
  • Before you start verification
  • Quiz - Before you start verification
  • Methods and validation
  • Quiz - Methods and validation
  • Change control
  • Change control
  • Quiz - Change control
  • How it all fits together
  • How it all fits together - Part 1
  • How it all fits together - Part 2
  • Quiz - How it all fits together
  • Final exam
  • Final Exam - Design control
  • Course evaluation
  • Course evaluation
  • Conclusion

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