ABSTRACT
Design reviews should be conducted at major decision points or milestones in the device’s development cycle to provide assurance that an activity or design phase has been completed in an acceptable manner. Each design review needs to also include an individual who is independent from the design stage being reviewed. This is done simply to ensure a fresh perspective based on the principle that those who are too close to the design may overlook design errors. The team members should be able to independently represent their own particular field and function and to present their opinions, recommendations, and requirements constructively. The design team should be encouraged to work together to find solutions to any problems identified. The team should then discuss the concerns raised during the evaluation portion of the meeting and decide on an appropriate action for each problem identified.
