There can be a lot of reasons to change a device and as long as it doesn't effect he safety, efficacy or performance of the device, there shouldn't be...

At work we were working on a project to develop a new diagnostic test. We hit a road bump about 2 weeks prior to turning over the project to manufactu...

I recently have found it interesting at my job how different the metrics can be based on what upper management deems a quality project or not. It's pr...

To add on, this will let the team and upper management decide whether or not a project is worth following through on if it hits too many road bumps. I...

There was a project that I was on that we should have spent more time in the research phase. We were culturing cells for this project and there was on...

I work at a very small company so they assume that they do not need to complete WBS at all. So this accounts for everyone taking on more responsibilit...

One of the manufacturing projects that my team works on at my company, was delayed because of an issue in the biology department. The cell biology dep...

Catheter with antimicrobial coating is another example of a combination product. This allows the catheter to function as it is intended but prevents c...

I agree with everything said so far. This is more an example of where having an interpersonal "beef" with another employee caused a long delay in the ...

Currently, I work for Scimedx, a small diagnostic medical device company. Since the company is small (only about 30 people) its a little harder to des...

To add on to what aij5 has said, there is also legal liabilities that companies should make sure that they have covered. If a product goes out to mark...

This one might be a layup but a pretty common one would be a first aid kit. They have aspririn and antibiotic cream that would go through CDER which a...

I think there is the assumption that engineers will be well equipped enough in their jobs that they can learn and evolve throughout the entire process...