I recently worked on a product that was recalled voluntarily by our company. I want to make the distinction between a voluntary recall and an FDA mandated recall. A voluntary recall is when a company'...

A de Novo is a classification process using a risk-based strategy for new, novel devices that have not been classified as of yet. The new ruling in 2014 streamlined the process by creating an alternat...

The question was raised whether the current 510(k) process is ensuring that the medical devices released to the market are safe and effective. The Institute of Medicine (IOM) investigated this questio...

I work in Product Development, and what I would say is that in industry, timing can determine the success or failure of a product, therefore I believe that industrial research is approached in a diffe...

First of all, I think that the decision to outsource to this university just because a team member has connections there is a poor decision. In a best case scenario (which is probably what was assumed...

As the others have mentioned already, referencing the Toxicity Table from ISO 10993, there are different tests required for different applications. Therefore, if you know what application you are plan...

I worked on a project that was so volatile during the execution phase that it really did not follow any plan, and eventually it was cancelled. It really was a complete failure. One of the main contrib...

I'm wondering if any of you have experience working on a project where there were multiple project managers who each were responsible for different portions of the project rather than just one project...

Many of the posts above mention the regulatory aspect of project management as a greater challenge in the medical device industry. I do agree with this, but I would like to expand on what ao242 mentio...

I have been working as a Product Development Engineer for 2 years in the medical device industry. My team is focused on designing implants and instruments for spine surgery. Overall, I really enjoy my...

I have only been working in industry, so I cannot speak to the differences between academia and industry. However, I can speak to what I have experienced in industry. My job is very structured, in tha...

I think that the answer to this question is highly dependent on the individual, depending on what they are looking to get out of their MS degree. For me personally, I think that a 50/50 ratio would be...