At the medical device company I work at, our marketing team focuses on actively following the customers who continue to buy our products. They stay on top of any issues the customer has in terms of ma...

As an engineer that currently uses 3D printing, most 3D printing applications have been used toward manufacturing equipment and fixing parts as opposed to 3D printing actual devices. Most items I am 3...

Has anyone ever been laid off of a job that required them to accept a severance and release agreement? Basically the company gives you some form of compensation in exchange for agreeing not to sue th...

I believe when you move from one medical device company to another, as part of the application or on-boarding process they ask "Have you worked for a company in which you are legally non-competing or ...

Has anyone ever worked for a company in which that company was sold off and every employee became legally a ring-fenced employee? Essentially the employee has a certain time period where they cannot ...

This course was excellent in giving a high overview of how the medical device industry functions. The lectures were really informative and gave me a better understanding about departments that I work ...

Agree with this. Competition is always good to keep people motivated to bring their best each and everyday. However, if its taken to the point where one is stepping on someone else to move up or get...

A small part of the lecture reviewed Upper Management vs Middle Management. Upper Management people are strategic and tend to set the groundwork and vision for what the company could be. Middle Manag...

I work in an organization that is both Functional and a Matrix organization. We essentially use project managers within departments that lead the projects with a staff beneath them. Most of the proj...

A lot of companies and regulators such as BSI, put a lot of time and effort to ensure that the IFUs and graphic labels on the product match. I can see both sides why this is important and why this co...

It helps if a similar product is already approved in whatever country the company is trying to release their product. If it is a whole new product that is being brought to market most of the cost are ...

Point #4 - Risk Management is not a lifecycle process is one of the most common errors that occurs for most companies when they assess risk management. Risk management is done at the beginning stages...

In agreement with this post. AQL levels for most companies are the guideline for identifying what the sample size should be depending on the risk. However, further analysis such as power level, signi...

Agree with this in terms of having an established amount of lots, units, and time for running the validation. If you are conducting a validation you would want to prove that a set amount of lots or u...

For the Verification step, a test is generated to ensure the design outputs meet the design input requirements. If the test doesn't pass, then a deviation essentially occurs. Has anyone encountered ...