Document control of a QA department is meant to assure that all documentation for a project is in order so when the FDA or some other organization comes for an audit, for example, the company team is prepared to show…   Read more»

I feel as though both sides have valid concerns in how a project should proceed. On the R&D hand, you have legitimate data and statistic to prove that the project is good to continue. Quality on the other hand have…   Read more»

To those who say quality is a burden I can see where they’re coming from. With QA/QC in place, a lot of money has to thrown into a process that hinders the launch of a product, but it is a…   Read more»

I personally feel the FDA is in the right for being as strict as they are. In fact, they may not be strict enough as the products that get released into the market often get recalled after further investigation. I’d…   Read more»

Precision and accuracy play critical roles in medical device development as it is these factors that determine the validity of what a device claims to do. The FDA has guidelines that refer to calibration measures for instruments and such. In…   Read more»

Any medical device of any type can experience a recall for numerous different reasons. One prevailing issue that effects device such as sensor systems is the accuracy and precision of said medical device. Often times the FDA will shut down…   Read more»

As the other before me have said, the biomedical device will have to comply with ISO 10993. This means that the medical device in question cannot harm a subject depending on the application. This can be viewed in the toxicity…   Read more»

Research in academia is generally approached in the following manner: “I am curious about this subject and I want to delve deeper into it.” Research in academia generally stems from the thrill of discovery and requires a kind of passion…   Read more»

I personally would prefer to do research that can be utilized as soon as possible. There is that sense of instant gratification where you can see what you have created and see it be applied in the ‘real world’. I…   Read more»

I would say that the planning process is among the most important phases followed by the execution process. This is because the planning process is the time where a project’s execution is discussed and where all things leading up to…   Read more»

I never worked in industry, but for the Capstone class here in NJIT we used Microsoft Project in order to create an in depth schedule for our project. You’re able to use this in several views such as a Gantt…   Read more»

One of the biggest challenges of doing project management for a medical device as opposed to building a building is having to assure that the device in question is meeting vigorous FDA regulations and that all other documents such as…   Read more»

I personally never worked in the field, but I can share the advise other upperclassmen and advisors gave me. In my experience, landing an internship is not easy and from what I hear in some other fields may not be…   Read more»

If someone wanted to work in academia I would say academia is very research oriented and allows for great opportunities to discover new things and maybe even travel the world to share your knowledge. At the same time for academia,…   Read more»

The 3:7 ratio of practical classes to academic classes feels as though it is a missed opportunity; however, it could be worse. I’ll start by saying that I feel as though this ratio should be 1:1 or at least 4:6…   Read more»