The regulations are highly important in ensuring that the product follows the correct standards and is safe to use in the medical device market. It does seem a little unfair that the company has to p...

Project Risk Management works to manage the possible risks a project may have and how to fix it. With Project Risk Management, projects are planned to have fewer risks. With Risk Identification, the...

As stated previously, the risk-benefit analysis is an important, when determining the benefits and risks that need to be considered for a product. One of the factors that is considered in the analys...

Validation is always an important step in the Design Controls. However, it is not necessarily always needed if there are no changes like you mentioned. Although that might be the case, I feel that a...

Syringes are commonly used in medical care, such as for intravenous injection in hospitals. Syringes need to be tested and verified before even being used. Some of the tests used to determine the pe...

The Verification step is a very important factor when understanding Design Controls. If the design does not pass the Verification Test, there could be a high risk factor. Although I have not persona...

When determining design inputs it is very important to consider physical and performance traits. These two aspects will determine the used when designing the device. For instance, when considering t...

A Gantt chart gives a detailed schedule in order to complete a project successfully. A major factor in the Gantt chart is the critical path. The critical path ensures that specific steps of the proj...

Taking minutes in meetings and reviewing them after are very important. They often provide when certain projects are due and what is needed to be completed. If you miss something in a meeting or for...

Clinical research allows for the growth of the research being done. Essentially, it includes humans as subjects to determine the effectiveness of the product. One major aspect that needs to be consi...

I do agree that the Lacks family should receive some sort of compensation or acknowledgment for the amount research that has been completed and is still being completed using the HeLa cells. It is et...

The Placebo-controlled trials are very beneficial in determining the efficiency of a product. With the Placebo trials, one group of subjects receives the real product, while the other group receives ...

Costco Wholesale is a company that does not use television advertisement, and has been very successful. There are four ways of promoting that the company uses to best market their products, which are...

The medical device company I chose to look at is Johnson & Johnson. Johnson & Johnson is a major global healthcare company that has many different divisions, which include consumer products,...

In this week’s lecture we discussed how there is a grand strategy in the marketing plan. There are different types of grand strategies used according to what a company feels is best fit. I was wonde...