Module 14: Design Development and Certification of Medical Devices

Evaluating medical devices in Human Factors and Usability Studies

Key elements that studies and tests look at – ❑ The intended users ❑ The use environments ❑ The user interfaces

Most studies and tests are performed with – ❑ Nurses (Hospital, Care-Home, Community, Specialist etc.) ❑ Patients with the conditions/injuries/medical condition ❑ Personal/professional Carers who manage the patient(s) Most studies and test are performed focusing on how the medical device interacts with the patient's body: ❑ Orally ❑ Through surgery/intervention ❑ By injection/infusion ❑ Through the skin ❑ By inhalation ❑ Through absorption

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development