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 medical device company, it is all about what happens after Design Transfer. Because of the nature of the work I am involved in, I am more attuned to the…[Read more]

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 been able to suggest logical solutions. In the opposite manner, these simulations have also been helpful in gaining a better understanding of terms…[Read more]

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 the previous course, Medical Device Development, I was the clinical trial member. The work seemed to be very hands on and more interactive with the…[Read more]

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 of these trials makes a difference, however. For example, if it is in an area with unsafe water for consumption and the clinical trial requires…[Read more]

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 throughout the entirety of the trial. If at any point the consent is to be withdrawn, the company must respect that. In the event of unexpected or…[Read more]

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, they are blind to the intrinsic problems that occur. By enlightening management to what is needed from the engineering perspective, the QMS as a…[Read more]

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 human error from an operator. This non-conformance can be fixed through a rework unless the problem is too big to salvage the product, in which case…[Read more]

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 leaves the production floor. For example, if there is a hole in the membrane it can be replaced if caught early on. This correction fixes something…[Read more]

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 system in place for the company’s QSR. Where I work, the GMPs are very well established and are rarely changed. If there is a change in the GMP,…[Read more]

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 are used to anticipate what can go wrong and try to fix it before the device reaches the market. Since it is impossible to foresee everything,…[Read more]

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 System. Internal audits are less variable than one from a private company or the FDA or ISO. I have taken part in an internal audit, and we had a day…[Read more]

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 to ensure a safe and effective device throughout the entire life cycle. In the maturity phase, the SOPs and specs and all the documentation that…[Read more]