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So it can be used as part of a project pitch to potential investors.

It is a legal requirement for all medical products

So you have a record of all the design decisions made throughout a project.

It provides a checklist to make sure you’ve considered and planned all aspects of product development.

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It contains a record of all the design decisions made in a project and why you made them.

It is a requirement for any submission for approval to the FDA.

It must be contained within a single spreadsheet.

It is recommended to build it into your workflow rather than try to complete it at the end.

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Failure mode.

Individual responsible for causing risk.

Failure impact.

Date risk occurred.

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User research.

Weekly client reviews

Iterative sprints.

Design verification.

Check your knowledge