If the risk has been deemed acceptable enough to reach the end user then I believe the best way to mitigate the risk is to have a scrupulously detailed Instructions For Use (IFU). Sometimes companies ...

You mentioned two of the big factors: Severity (S) of the failure and Occurrence (O) of the failure. These determine how serious the problem is, and how often it happens. A third factor which my compa...

I would like to point out that no matter how creative and methodical you are, there will be risks that you will not be aware of until something goes wrong. The Failure Mode and Effects Analysis tool i...

The Design Input Document (DID) and Design Specification Document (DSD) are very similar, but I think they belong to distinctly different steps in the product development life cycle. The DID is meant ...

Working in industry, I am aware of design review meetings which happen almost weekly. One of the many engineers will have some sort of change which affects the inputs or outputs of the process or prod...

As mentioned above, verification is one of the most integral parts of the design control process and probably where engineers encounter the most problems. This is the first step where you really get t...

I think this law is huge step forward on the clinical world. I can only imagine the difficulty that comes with finding willing participants for certain experiments. Dr. Simon mentioned some college bu...

Personally, I do not agree with either statement made above. First, I am sure there are medical devices which have failed to improve human well-being or have even backfired and caused unintentional ha...

I think it is very situational as to the qualifications for each position involved in the clinical. The investigator is someone who should probably have a clinical background, but may pass if they hav...

This was a very creative form of satire which highlights sometimes the disconnect between management and engineering. Obviously there were some requirements which were laid out in this video and the l...

I do agree to a certain extent that marketing has a manipulative aspect to it, but it depends on the product. Manipulation implies there is deceit behind the veil of the advertisement. If a company is...

One popular trend in the social media era of today is marketing products through popular influencers on various sites. This is probably most prevalent on Instagram where people can seamlessly integrat...

Partnerships are sometimes a good idea, but you need a strong foundation to build off of. All throughout college you are apart of different class projects in which you must rely on people to make cert...

There are several key differences between public and private companies. Public companies can be owned by an almost unlimited amount of shareholders and stocks are traded publicly on the stock market. ...

I think it all comes down to the type of person you inherently are: risk-averse tolerant. This is usually applied when talking about investing in money, but can also be applied here when undertaking a...