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 job after my graduating from college I had no idea what to expect. All I wanted to do was to get a job and start making money…[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 in my career I was told to concentrate on the skills required for the job and not to concentrate on…[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 of communication may create distrust and uncertainty in a workplace. This often leads to lower employee…[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 to determine your future within the company. In this kind of establishment if the functional head likes you, you are bound to succeed and…[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 determine the region the risks fall in (this will help determine the probability and impact for that risk)
Risks…[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 it will take to avoid that risk. This would be a good strategy to implement if it involves a very small risk.

Risk control involves…[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 production and post production information

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 records necessary to demonstrate the design was developed in accordance with the designed plan and…[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 problems a team may encounter. A detailed thinking will help ensure that a designed schedule is workable, and that the right…[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 evaluates a design against its requirements by taking into consideration the physical tests…[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 table of contents could be found at the FDA link…[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 at the time of approval which may lead to a quicker approval.

Being that the DHF has more detailed information from day one to…[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 have referenced these documents for daily tasks. This document also helps when one is out of…[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 working with quality assurance monitor and data management staff to identify and resolve…[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 studies for publication. It could be that individuals with…[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 to provide patients with the latest and newest treatments available. It may also be the only hope a patient may have if this…[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, internet, mobile phone and retail stores by providing discounts.
Social media…[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. This is especially important with the economy going global, since people interact with different…[Read more]

Mission statement – a brief summary on the values of a company/organization
Vision statement – A depiction of what a company/organization strives to achieve in the future. It is meant to function as a guide for making future decisions.
They are both important since they both determine the company’s direction and end goals. They serve as a guide…[Read more]

I would take the LLC route:

LLCs protect its members from being held personally responsible for the actions of the LLC. The limited liability protects you from the personal risks involved if a lawsuit were to arise concerning your business thus safeguarding your personal assets.
LLCs are not required to keep extensive records and in some states…[Read more]