Due to the PMI website, these are some of the challenges that project managers could face: 1) Ensuring Project Success 2) Preventing Project Failures 3) Enhancing Project Competencies — I would elaborate on the first point from my point of…   Read more»

As others mentioned, the whole timeline should be reviewed by the project manager and the timeframe for each phase should be reevaluated. Since the device failed in performing its major task as a weight loss aid, more research should be…   Read more»

I don’t think there is a specific way that is the “most efficient” way to brings DID specification to the device. It depends on the device type, design team, etc. I would agree with other replies above, which emphasize that…   Read more»

Design validation is an important factor in project management as it will determine the needed deliverable to ensure that the correct product with the aimed solutions will be delivered to the customers’ needs. In the medical devices industry, in particular,…   Read more»

I have always believed that the overwhelming outcome of shared resources and collaborations would lead to a positive outcome. One of the main benefits of global regulation of medical devices is that scientists and research groups in one country would…   Read more»

In this week simulation, the experiment forced the team to follow a specific resolving its failure as the project deliverables were stated and the protocol followed in the lab was clarified. In my opinion, it was good to think first…   Read more»

Interpersonal skills are the most important qualification an employee can have in my opinion. We all came from an academic background and have certainly encountered many individuals whos interpersonal skills have inspired us. For example, I remember as a freshman…   Read more»

Although FDA approval is very useful to protect public health thru controlling medical devices and pharmaceutical drugs and ensure safety and effectiveness. Some of the most important points to be followed by the design process team in order to ensure…   Read more»

“While physicians may prescribe medical devices for unapproved uses, a manufacturer may not distribute medical devices in interstate commerce with the intent that those devices be used for unapproved purposes” This sentence in an article on whistleblowerfirm website grabbed my…   Read more»

A risk is an event or condition that, if it occurs, could have a positive or negative effect on a project’s objectives. Risk Management is defined as the process of recognizing, classifying, evaluating, responding to and managing risks that could…   Read more»

Quality plans are essential in any project, although in many cases the project manager won’t give it the priority. QP can be defined in project management as “a set of planned, systematic actions to ensure that products and services comply…   Read more»

As a biomedical engineering graduate student, I would say one in this field would need both skills (interpersonal skills and technical skills) in a ratio of 50:50. Although I agreed in an earlier reply that “interpersonal skills are more essential…   Read more»

I would agree with the reviews above which thinks that a product with a peeled off label or similar defects should still be recalled as they may lead to a severe dangerous consequence in some cases. For example, a pain…   Read more»

I believe that interpersonal skills are more essential to the work environment especially to teamwork oriented place than technical skills. For example, an engineer could be top-notch in his/her technical skills, but if he/she fails in communicating and explaining their…   Read more»

Having the right people in the right place in the project would absolutely make the project manager life easier and would make the project flow smoother and would ensure the project success. Choosing the proper team member doesn’t necessary means…   Read more»

A project manager should have multiple skills including: “- Leadership – provide direction – provide vision – coach/mentor team members – sound judgment – issue & conflict resolution – effective decision making – Negotiation – Communication – Team building” [Ref….   Read more»

I think these restrictions are essentials and would help physicians and employers to avoid many problems at work. I think without any gifts restrictions, some people would go crazy thinking that the more expensive the gift we give is the…   Read more»

I agree with most replies here, which finds a written business agreement the better option in a project, compared to the verbal agreement, as it and can be easily defended in court and would provide more certainty by stating the…   Read more»

This was my first online course in my Master degree, and I enjoyed it a lot, and never regret taking it. I like how we learned about different aspects every week, and how this course taught me a lot about…   Read more»

I personally find my talents, skills, and qualifications are more suited for upper management. I believe that what makes a good upper management individual is someone whose leadership skills are strong in the sense that he or she can lead…   Read more»