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...

I appreciated going through the simulations each week. It was a more hands-on experience of everything that the course has been teaching through lectu...

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...

Executing a clinical trial can take large budgets to complete. To compete with this, companies tend to use developing countries as their regulations a...

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 t...

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 ...

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 singu...

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 wou...

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 differ...

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 pos...

Internal audits are essential to medical device companies because this creates a controlled environment in which the company can comprehensively evalu...

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 rea...

Since the development phase of production is one of the most expensive parts of production, I think a company, depending on their resources and priori...

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, every...

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 eve...