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 in different manners depending on the state law and interpretations…   Read more»

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 government reached the largest-ever settlement at the time…   Read more»

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. When I took my first…   Read more»

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 who is specific for the project. At some point…   Read more»

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 basic communication becomes a problem. This lack…   Read more»

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 the power…   Read more»

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 manager should create a chart which will…   Read more»

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 the added cost…   Read more»

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 evaluation, risk controls, overall residual risk acceptability, risk management report and…   Read more»

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 FDA the design history should contain all the…   Read more»

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 should also include the…   Read more»

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 and identify issues before committing. The design review…   Read more»

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 add to what was posted by hv24, a sample…   Read more»

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 is not required…   Read more»

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 are discussed are documented. On several occasions I…   Read more»

Being a research coordinator would be my role of interest. This position requires that the study data is accurately captured and reported. The role also involves reporting any study or participant issues, maintaining regulatory files at the study site and…   Read more»

Having a clinical background may be advantageous to understanding all aspects of the research. It may also be advantageous when dealing with patient care, collecting data on treatments effectiveness, studying and reading medical journals, evaluation of previous research and research…   Read more»

A clinical trial has various advantages depending on which side of the fence you one may stand. It may serve as an additional source of income for doctors and nurses. At the same time physicians and nurses may be delighted…   Read more»

Currently some of the strategies being used include multi-channel analytics. This process uses multiple sets of data from different sources which are linked and housed together. Businesses then use this information to interact with clients through the use of Apps,…   Read more»

What is EI? EI is defined as being able to understand moods, behavior and impulses and control them to match a certain situation. One should possess the capability to exhibit mature emotions to better understand, negotiate, and sympathize with others….   Read more»