Quality Chapter 11

Identifying known or foreseeable hazards or hazardous situations is unnecessary in the design of medical devices

Current FDA guidance suggests that medical devices should notify users if a potential cybersecurity breach is detected

What does conducting validation testing with human factors protocol ensure?

What should be included in a specification for a medical device?

User interface evaluation plan is designed to assess the usability and safety of the user interface of a medical device

The primary goal of the HFE/UE process is to minimize use-related hazards and risks

It is not necessary to identify the environment in which the device will be used during the early stages of design

Why is it important to identify hazardous-related use scenarios?

FDA’s guidance doesn't require devices to protect their critical functionality when impaired by a cybersecurity incident

What is one of the early considerations in the Human Factor Engineering (HFE) process?

Why is it important to identify user interfaces and critical tasks early in the HFE process?

What is the term used for HFE in the earliest stages of design and development?

HFE should be considered during the earliest stages of design and development?

What is the main goal of Human Factor Engineering (HFE) in medical devices?