Module 14: Design Development and Certification of Medical Devices

17/11/2023

Inherent elements of RISK

◦ Use in / for patients ◦ Underlying disease state / physical condition ◦ Some immunocompromised ◦ Requiring treatment or diagnosis ◦ Requires human intervention ◦ Self-administered or given by healthcare provider ◦ Usability / intuitive use?

Masterclass: Lecture 2

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Inherent elements of RISK

◦ Design and performance ◦ Day to day performance and reliability ◦ Choice of materials ◦ Manufacturing consistency

◦ Misuse and abuse ◦ …the device may not be actually used as intended…

Masterclass: Lecture 2

38

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