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 specifications.
Lack of user-friendliness.
In addition to identification, the time period for risk is as long as the product or the device is active.…[Read more]

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 period that their negative effects (i.e., injuries) would, in fact, be cumulative. Based on the critical factors associated with summing the severity of…[Read more]

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 control of possible future events and is proactive rather than reactive.
The acceptance or non-acceptance of a risk is usually dependent on the project…[Read more]

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 compatibility of materials, Sterilization tests are the most commonly performed tests. After the tests are conducted, inspection and analyses is carried…[Read more]

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 must dovetail with the Design Transfer Procedure to make sure the correct information is provided to the company’s management staff in the pro…[Read more]

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 must dovetail with the Design Transfer Procedure to make sure the correct information is provided to the company’s management staff in the pro…[Read more]

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 provides the following:
1. It’s main purpose is to treat irreversible disease ad life threatening conditions.
2.It clears way to new upcoming…[Read more]