Picking a project team is probably the most crucial task and hardest challenge for a project leader. There is no absolute right/wrong answer when picking a team as individuals have different strengths and weaknesses which can either strengthen or weaken the team, respectively. In other words, there is never a perfect team but the key is to find…[Read more]

I do believe that the medical device community is progressing towards a global system of regulating medical devices. I think that as more countries get more industrialized and gain more technology, countries will “go with the flow” and adopt regulatory procedures and protocols followed by other countries to enhance quality of their products. I…[Read more]

The quality plan is needed for many different reasons. The quality plan document verifies the internal and external standards and procedures. Besides that, the document also provides some insight as the business’ quality management system because it requires one to gather information regarding the quality assurance methods, specifically the…[Read more]

Some advantages of the Functional Organization is that the departments operate somewhat independently of each other so coordination between members of a department is much easier because they can only rely on each other during a project. All decisions are made by one individual, the Functional Manager, which is efficient because decisions will be…[Read more]

The way that I think about a project proposal document is that it is a formal way of persuading the leaders of your company, such as CEOs, managers, and stakeholders, that your project is worth investing in and that it’s the better or best option out of all their choices. The project proposal document introduces the specific problem that you are…[Read more]

I think that this would depend on the information on the labels of the products. If there were important safety information or details regarding use, then the product should be recalled because customers will complain about the product if it causes problems or fails to perform as expected. I don;t believe that the answer is one or the other, the…[Read more]

I think that the company should fund the project if it has sufficient funds. If the firm doesn’t have enough to fund two or more proposed projects, then the one that offers the least risk or requires less money should be taken first and the bigger project should be pushed farther back. The reason is because funding big projects is quite risky…[Read more]

I believe that it’s extremely important for an employee to be able to pick a good group of people for a project team because doing a project is a team effort. Not only does it matter that each individual member is qualified or able to do his/her own part in the project but they must be able to work effectively and smoothly. This is what makes…[Read more]

The reason why formulating the project idea is the hardest part is because it is the foundation for the entire project. The project that you run is meant to turn your ideas into reality. Without a solid idea, you cannot create something new or innovative. Another way to think about is asking yourself the question: how do you plan on hitting a…[Read more]

I think that the BME curriculum does not reflect the author’s perspective because there are virtually no courses that teach interpersonal skills. However, I think that the investment is still justified because it’s important for future engineers to know the material and have high-skill in their area. Interpersonal skills are something that should…[Read more]

I actually agree with the statement that interpersonal skills should be valued more than technical skills or book knowledge. My reasoning is that in my experience, people who are skilled at dealing with people and know how to work with others are the ones who end up with higher-paying jobs and have more achievement. I know that employers strive to…[Read more]

Verbal means any communication that involves words, which means that oral and written agreements are both verbal agreements. I think you meant “what is the difference between Oral and Written Agreements?” An oral agreement is harder to prove because it is based on communication between two or more parties. There must be agreement and consistency…[Read more]

In my opinion, I understand why this may seem pretty awkward and I don’t think it’s a problem at all to pay for the physician’s wife but I do see the reasoning behind it. The physician could bring more colleagues and family members (e.g. brothers and sisters involved in the field) and try to exploit the company’s generosity. I think that this is…[Read more]

Overall, I thought that the content of this course was excellent. One thing that I particularly found helpful were the lecture presentation slides. The content in the slides were pretty clear and concise. This is my first online course in my academic career so it was a pretty good experience in being an online course. I liked the fact there…[Read more]

For my team, I completed the DID and my partner completed the RA document. We haven’t had our first meeting yet due to conflicts but so far the project is going quite smoothly. One of the challenging things about working on my team is coordinating in-person meetings because it’s very hard to get people together at the same time because of course…[Read more]

Organizational culture and structure can influence a project in many different ways. It will definitely impact what resources the business is willing to allocate for your project and how quickly and efficiently it can be done. Sometimes, the problem with following through on a project may not be internal, rather external because there are some…[Read more]

For selecting members for my project team, I would look at what individuals are very enthusiastic or very interested to join in on the project. Having people who are curious and committed is crucial because if they lack interest of have a bad attitude, that will be shown in their performance and results. Then, I would look at what the requirements…[Read more]

In my opinion, I would say that avoidance is the best option for high severity of risk because this level of risk is something that can have detrimental effects on a business. A s Benjamin Franklin once stated, ” An ounce of prevention is worth a pound of cures.” Companies should look to prevent high risks because if those risks cause those…[Read more]

The way that I interpret this regulation is that companies have to prove that their manufacturing processes are performing at the most optimal level possible. It’s impossible to have a 100% efficient system, many of the things that happen in nature (e.g. chemical reactions, space phenomenon) generate waste and increase the entropy of the universe.…[Read more]

I think that using these regulations costs money simply because it’s a service that businesses and companies can use to show that they are complying with regulations and not trying to take the easy way out when it comes to making medical devices. Writing these regulations and standards were the result of effort and hard work and I think that the…[Read more]