The roles in the quality team vary between companies. Because I work in a very small company, the quality assurance and quality control team consist of the QA engineer/associate, a documents specialis...

I can see some of the value of the 510(k). It could make the process more efficient. If a company can prove some similarity to a pre-existing, successful device, then they can use the existing researc...

As my work is currently in the process of getting a medical device FDA approved, I understand where the frustration comes from with how strict and lengthy the FDA process is. However, I do not think t...

While I certainly agree with those who say that the FDA process could be made more efficient with an increase in workforce, I don't believe that the FDA process can really be accelerated. The phases i...

As many have stated before, I do agree that missing a milestone is going to be typically looked at as a failure. Regardless of the reason for missing the milestone, it reflects poor planning or poor e...

Recently, I encountered an obstacle at work that certainly could have been avoided if my team and I spent more time planning out the project. Our product requires to be sent out for sterilization as w...

I do believe that virtual communications have helped improve project life cycles to some degree. As a result of the COVID-19 pandemic, virtual communication has certainly improved as we now have plent...

As many of the previous posts have stated, a 30/70 practical to academic ratio is not the best. I, like many, learn better from hands-on experience. Courses aimed at teaching you the practical applica...

I certainly agree with many of the advantages and disadvantages made in the previous posts. Initially, when deciding to pursue a BME degree, I was drawn to the idea of being exposed to different areas...

I began my R&D role in the company I currently work for in the midst of the COVID-19 pandemic. Unlike many people who began working or worked through the pandemic, I was always required to be onsi...

Because projects can last for years, it is not surprising that in that time team members may leave/quit or members change positions. Usually, if the employee is making the decision to leave, they shou...

It is important that the product you produce is within the specifications that you set. These specifications are set to ensure that your product is not only able to do what its intended to do but can ...

To answer the first question, effective communication is achieved by every member of a project, regardless of size or role. It is important that project team members maintain constant communication wi...

I agree that project cost can never be accurately established at the beginning of the project. There are factors that may come up that may not have been planned for in the beginning of the project. In...

I agree that those 5 factors are important for the success of any project, especially effective communication. In a project where there may be several departments and a lot of people working in collab...