Non-disclosure agreements can be defined as an agreement by which companies or various individuals agree to keep information confidential. NDA is a contract and not a law. Contracts are interpreted ...

Even though this article is dated 2009, Pfizer was asked to pay $2.3 billion dollars to settle allegations of kickbacks in off-label marketing campaign. Per the article 49 states and the federal gove...

This course has shed some light on the medical device industry. This course gives you the opportunity to have some understanding of what is expected of you when you work for a medical device company....

Select your team by choosing the right people. Select these individuals for their skills and abilities. One does not necessarily need the most qualified person but one should consider an individual w...

I also agree with Adrian. I have worked with establishments where different companies have come together to work on a project and some of these companies have actually merged. Believe it or not basi...

I used to work in a functional organization where the functional head has a lot of power. From what I have observed they make most of the decisions. They choose who can work on what project and have ...

Before the meeting the risk manager should compile a list of risks The manager should also entertain a list of risks from the team Categorize the risks for easy identification of duplicates The manage...

For low severity I would rely on accepting the risk. Accepting the risk occurs when the price to pay for managing a type of risk is accepted due to the risk involved not adequate enough to warrant th...

Risk management regulation is based on safety, quality and efficacy. It requires that the company creates a risk management policy that includes planning of risk management, risk analysis, risk evalua...

Device history file - Each medical device has a document that displays the design history. This document is initiated as the design starts and moves on through development process. According to the ...

For the Gantt chart you need to think through all the tasks involved in your project. The process will include working out who is responsible for each task and how long the task will take. One shoul...

Project review meetings bring together the best employees the company has to offer. The idea is to evaluate the design against its requirements in order to verify the outcomes of previous activities ...

Per the FDA site the regulation dos not prescribe the practices that must be used instead it establishes a framework that manufacturers must use when developing and implementing design controls. To ...

If one desires to reproduce the device then the DHF will be the way to go. For a summary I believe the tech file would be more useful. The tech file might eliminate the cumbersome information that i...

Meeting minutes are very important in every company I have worked for since graduating. The current company I work for uses sharepoint to track all meeting minutes. All changes to regulations that ar...