Posted by: @266 Academically speaking, would you rather be overqualified for your job or meet the bare minimum qualifications? What are some short term and long term pros/cons for either situation? Academically speaking, I would rather meet the bare minimum…   Read more»

Posted by: @orleron We are meeting in an interesting time, to say the least.  As a disease, covid19 has many elements to its treatment and many of those elements use medical devices.  There are ventilators and syringes, which we all…   Read more»

Posted by: @bb254 Based on your work experience in any company, what were some issues you found with the quality department and how would you fix them? For example:I work in the manufacturing department of a medical device company but…   Read more»

Posted by: @hruship101 Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it means to delay product launch or to prevent the…   Read more»

The head of a quality team is a quality manager.  This role consist of a person who makes all of the quality decisions.  In my field of work, industrial, those decisions entail releasing a product if it has an out…   Read more»

In case of emergency, physicians can use medical devices if they haven’t been approved by the FDA yet if it will help cure their patient.  The physicians is given a go to use an unapproved device if: 1. The patient…   Read more»

Posted by: @mejefferson The Global Harmonization Task Force (GHTF) which is currently the International Medical Device Regulators Forum (IMDRF), has a goal of bringing together medical device regulatory systems around the world by enhancing patient safety and increasing access to…   Read more»

The classes are ranked according to their risk, or their safety and efficacy as mentioned above.  Class 2 medical devices are those that have moderate to high risk to patients. The only thing I really found on Class 2 medical…   Read more»

Good question Meagan.  I feel like these upper management positions should be filled with staff members who understands the business and works their way up.  I feel this way because, being a staff member myself, I feel like I can…   Read more»

Posted by: @rowel2202 When have your organizational skills helped keep a project on track? Does the organizational structure your work in determine how you prioritize the workload? or do you have a set system regardless of leadership ? My organizational…   Read more»

Posted by: @zcornelius21 What are the advantages of grouping projects under a program? The advantages of grouping project under a program is that you have the ability to initiate, define, accelerate or terminate projects in a program.  Another benefit is…   Read more»

Posted by: @devarshi-joshi According to me the most important 5 success factors are:1)Agreeing on the project goals2)Effective Communication3)Develop clearly defined plans with assigned responsibilities.4)Managing project scope effectively.5)Making sure of management support. So how are these factors individually important for a…   Read more»

As a lab technician, a huge part of our job is logging work because when we need it later on down the line we’ll have it stored so it can be easily found. At my former job, it was more…   Read more»

Posted by: @krp76 During the planning phase of a project estimations play a critical role. For medical device projects the cost estimation is not always straightforward as discussed in the lectures. Another estimation that can be misleading is the task…   Read more»

In this course I learned that there is a lot more to planning a project than what I thought.  I initially thought planning a project consisted of figuring out what the focus for the project would be and everything else…   Read more»

Posted by: @sp2387 Planning phase is the most important and basic phase according to me. If you are planning it should be practical because after all it has to be executed. Each and every step of any project should be…   Read more»

This would honestly be an easy fix as long as the team is fully staffed and proper protocols are followed.  If I was the PM, I would firstly make sure that my team is fully staffed and have multiple people…   Read more»

Posted by: @amin-sadig We learned a lot about scheduling and task delegation this week and one major question arose. If the PM changes at different phases of a project (beginning, mid, near conclusion), and the an error in the scope…   Read more»

Posted by: @amin-sadig From as early as the mini sim we were told to consider outside factors such as vacation times for inspectors when planning a schedule so we don’t get delayed unnecessarily. Because the job of a PA is…   Read more»