I believe that MDD and AMDD have been essential to my coursework here at NJIT. I am currently working in manufacturing engineering at a medical device company. In the manufacturing department of a med...

I appreciated going through the simulations each week. It was a more hands-on experience of everything that the course has been teaching through lectures. Using my current industry experience, I have ...

I am not personally involved in the clinical aspect of medical device development. However, in the future I would like to at one point be part of this process as it seems to be very interesting. In th...

Executing a clinical trial can take large budgets to complete. To compete with this, companies tend to use developing countries as their regulations are less strict or even non-existent. The location ...

If the subject were to undergo unexpected outcomes and no longer wants to take part in the trial, it is up to their discretion to continue or to end their treatment. Informed consent includes consent ...

With management, it is important to be open to communication while still maintaining a high level of respect. It is possible that since management is so far removed from the lower levels of the chain,...

Non-conformance can occur at any point in the production process, and this does not always indicate the need for a CAPA. A non-conformance for a singular unit of the device can just indicate a minor h...

In my experience, a correction can also be called a rework in which the product is fixed for a nonconformity. In the medical device industry, this would mean fixing the medical device before it even l...

Depending on how established the company is, GMPs may be constantly under appraisal in order to refine them. The changes can range from a minor difference in recording something to entirely modifying ...

The purpose of CAPAs is to ensure that the product is up to the highest consumer standards. The preventative actions are required to foresee every possible negative outcome. These preventative actions...

Internal audits are essential to medical device companies because this creates a controlled environment in which the company can comprehensively evaluate how they are doing in terms of their Quality S...

During the maturity phase of the product life cycle, it is important to be FDA and EU compliant. This product is now on the market and is used for real people. These FDA and EU guidelines are in place...

Since the development phase of production is one of the most expensive parts of production, I think a company, depending on their resources and priorities, should consider killing the project. This ca...

It is essential to have both accurate business knowledge as well as good interpersonal skills. This comes from any point of sales in any aspect, everything from clothing retail to medical device sales...

I find that the development phase can be the more expensive phase as not every investment made during this phase will ultimately have a pay off or even lead down the path that the company wants to go ...