Echoing several responses above, the PM has many important responsibilities. However, I believe that these responsibilities would not be as challengin...
This type of scenario was part of the mini-sim this week in which we were asked to deal with delays in timeline which happened due to incorrect task d...
One of approaches to take would be to look “easy” fixes first (e.g. improve packaging configuration first, then propose modifications to the device, t...
Risk/ Benefit Ratio is an assessment of the risks against their benefit. Ideally the benefit has to outweigh risks in order for the company to accept ...
A successful project will include risk management as part of planning phase. As stated by the professor, "if you fail to plan, plan to fail". Risk man...
It seems the company has a lot to worry about and updating the Gantt Chart may be the last of their worries. The balloon pops immediately instead of l...
I think another great example of process group within medical device are product complaints and change control that fall under monitoring and controll...
As mentioned in today’s lecture, often companies disregard project management with design controls thinking they are one and the same. This leaves gap...
The marketing team typically identifies the need based on market evaluation for a new product to be developed and often provides design inputs mostly ...
Selection of the members of the project team is extremely important in several ways. Obviously you desire the project team to be composed of people a ...
Based on the PMBOK, there are five phases of project management. Phase 1; Project Initiation - This is the start of the project, and the goal of this ...
In my opinion, it is very important that projects are properly prioritized and that every member of the team understands the details around priority ...
In agreement with some of what was described in previous posts, if the manufacturer is not the one claiming that the TJA total joint arthroplasty can ...
I believe no matter how flawless a medical device design and manufacturing process is, there is still potential for users to be harmed (e.g. use error...
Verification and validation are distinct, but related activities that combined demonstrate through objective evidence that the medical device meets th...