Non-disclosure agreements can be defined as an agreement by which companies or various individuals agree to keep information confidential. NDA is a c...
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 campaig...
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 ...
Select your team by choosing the right people. Select these individuals for their skills and abilities. One does not necessarily need the most qualif...
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 compa...
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. ...
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 risk...
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 t...
Risk management regulation is based on safety, quality and efficacy. It requires that the company creates a risk management policy that includes pla...
Device history file - Each medical device has a document that displays the design history. This document is initiated as the design starts and moves ...
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 eac...
Project review meetings bring together the best employees the company has to offer. The idea is to evaluate the design against its requirements in or...
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 ...
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...
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 m...