Quality Assurance involves performing activities necessary to ensure quality is being continuously maintained and improved on, and Quality Control involves actually identifying and measuring quality, ...

I am also in agreement that a new employee should not be hired in this case. Interviewing and selecting a good candidate, then having to train them on the job all to cover just a 3 month absence is co...

Many of the insulin therapy products used by individuals with diabetes can be considered combination products. The insulin itself is considered a drug, since it has the metabolic effect of lowering bl...

On several occasions during projects I've worked on, our project manager created a spreadsheet listing all the team members and when they were planning on taking PTO. This was located in the shared fi...

I worked on a project at my company involving a product that varied in design depending on the hospital's preferred configuration, so there were hundreds of components in our catalog for this product....

As a few of the posts above have stated, while the design team is working on the product development project, there should be a production team working in conjunction to ensure that production is read...

I think that since hazards are undesirable to come across in your project, then by definition a risk has a negative connotation, but the process of risk management is very beneficial and should be vie...

Change Control is implemented as part of the Monitoring & Controlling process of a project, and occurs throughout the entirety of the project. It basically entails measuring the current state of t...

As the posts above have stated, metrics are crucial in order to obtain the quantitative status of a project. Because of this, knowledge of software that can be used to track metrics is a useful skill ...

From my experience, at my company the WBS is integrated into the project's Gantt Chart. The highest level of the Gantt Chart will consist of the product development phases (Planning, Design and Develo...

As someone who is currently working in the medical device industry, I find the information discussed in this course to be very relevant to my day-to-day job. Even if you are an engineer, like myself, ...

At my company, we manufacture heart lung machines and disposible tubing kits to be used with the machines. These tubing kits are customized depending on the components and configuration desired by the...

As many of the posts above stated I agree that a lack of communication within a project team can be detrimental to the team's progress. That's why I also agree that establishing the expectations for c...

Design Validation is actually not always required in the product development process - a product may be sufficient with just Design Verification if it is a product that would not necessitate a clinica...

A challenge I've often faced when submitting a Change Notice at my company Getinge is that obtaining approval from all the required reviewers can take a while, since these reviewers are usually functi...