Module 14: Design Development and Certification of Medical Devices

Device Knowledge

Question – Where do people use rescue inhalers?

❑ At home? In which room?

❑ In a hospital or clinic? In which ward? In the Operating Room?

❑ At a sports field? In the changing room?

❑ In a restaurant? In public or in private in the toilets?

❑ Whilst travelling? In a car? On a train? On a plane?

The answer is anywhere. But why ? (Here we need to understand the clinical causes of the condition the patient has).

❑ Stress and exercise.

❑ Air restriction.

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development