Considering the fact that success is broken down to 70% interpersonal skills, I believe that there should be a stressed importance on developing interpersonal skills in educational degrees, regardless...

Both of these agreements can be enforced with valid evidence to back it up in case of any allegations held. However the main difference between these types of agreements is the chance of an individual...

Like many of my classmates have said, this course has provided me with a lot of useful information that goes beyond the BME curriculum, and teaches practical skills that is needed in the workforce. T...

Just a few days ago, Medtronic Spine is facing anti-kickback allegations for promoting a bone growth promoting device, Infuse (limited for use in the lower back) to physicians with methods not approve...

The key to a successful project is a successful team. I believe the best working teams succeed when there is no prior relationships between any of the team members. When it comes to choosing people fo...

I also agree with what has been said about the success of organizational structure. I believe it can be applied to any type of project and works great for medical device development. The culture this ...

When learning of the upper management role and the middle-man role, I initially thought I would be capable of taking on the upper management role. After doing some research on these two roles, along w...

Nowadays, people are willing to sue over anything and anyone. Therefore, companies must take all measures in avoiding, mitigating, transferring, and accepting risks without having any legal issues ari...

I think that it is fair. I do not think there is anything more a company can do to prevent an overdose for example after all the risks have en avoided or mitigated. On many pain killer bottles, there ...

A good way to run a risk management meeting is to plan ahead of time and leave the meeting with enough information to write a risk management plan. As part of the quality department, it is imperative ...

Like many of you have said, verification is key to a successful device that will benefit the end users. However, carrying through with this process is imperative to the success and potential risks a c...

When working in research, there is no standard design document when conducting an experiment as experiments are always subject to change. Let's take coming up with a new formulation for a hydrogel for...

I do not necessarily think that there are advantages versus disadvantages to these two documents as they both offer very crucial yet distinct purposes. The Design Input Document serves to provide the ...

Design inputs are mainly customer needs. An individual can come up with an innovative idea for a medical device, however it is the design inputs that will ultimately dictate what goes into the device ...

The quality of a product does not necessarily depend on how many regulatory rules there are. One can require hundreds of rules on a device yet produce a very low quality product. I believe that the st...