Risk identification and assessment can extend towards to human factors as well. The following are a few Devices used in an improper manner. Devices not manufactured and developed with appropriate spec...

According to an article, Summing the factors of all individual hazards to determine their cumulative effect is reasonably valid assuming all hazards occur simultaneously or within a short enough perio...

Risk Management is the process of identifying, analyzing and responding to risk factors throughout the life of a project and in the best interests of its objectives. Proper risk management implies con...

Verification and Validation go hand in hand. They cover every phase of product development and it is always considered from the very beginning. Material performance, Package quality tests, Bio compati...

A Design Transfer Procedure makes sure of mishaps do not occur during the transfer process. The procedure is typically overseen by the medical device company’s management. Design Change Procedures mu...

I would like to mention about EAP program, which stands for EXPEDITED ACCESS PATHWAY. It basically to aid and benefit patients who have not met their medical need, due to criteria issues. This program...