The FDA’s QSR part 820 outlines the requirements for maintaining the quality, safety, and effectiveness of medical devices. It also ensures that the medical device manufacturing process is compliant w...

Although testing is a significant component of the slowdown behind the FDA process of medical devices, other components also impact the deceleration of the process. One of the components is meeting th...

Some biocompatibility testing techniques include cytotoxicity testing, hemocompatibility testing, and implantation testing. All of these testing methods can be conducted either in vitro or in vivo. Cy...

The research path for making medical devices depends on the career goals an individual is trying to achieve. In terms of academia, the research for medical devices would be more focused on the academi...

Both academia and industry research are vastly different but similar in some aspects. For academia, expertise in grant writing and deep research skills are needed. For academia, a project is funded th...

Although academia and industry are quite different, they both use project management strategies to reach their end goal. It is true that in industry the strategies are more structured with feasible de...

In my opinion, the most affected stakeholder group would be the investors. Factors such as revenue and press recognition would affect the investor's financial impact. For example, abundant revenue and...

There are multiple ways one can ensure that the quality of a project is being held to a certain standard and that the risks are being adequately mitigated to not throw off the entire project. One of t...

I believe that as a major, BME is facing the issue of not being broad enough. At NJIT students are encouraged to choose their track (biomaterials, biomechanics, or medical device and imaging) as soon ...

Like many others, I agree that students in BME should be familiar with various coding languages. However, it also depends on the type of specialization that the student is pursuing that defines how ad...

Although Telehealth has provided more access to healthcare, I believe it also has caused more harm. After having the opportunity to shadow different clinicians, I was able to observe first-hand the ef...