As with risk management, verification and validation are essential topics that must be investigated separately in order to make sure they are fully understood. Yet these are integral steps in the...
Design outputs are the result of each design phase and of the entire design effort. A completed and finished design will culminate in the device itself, its labeling and packaging, and the device...
While the word “design” often suggests a creative, trial-and-error process, design, as it applies to medical devices, must be a well-controlled, thoroughly documented process. Design controls are...
When developing a new device using Human Factors Engineering (HFE), researching known use- and design-related issues and hazards that have already been identified for devices similar to yours – or...
