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 mand...

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 20...

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 Ins...

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...

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...

As the others have mentioned already, referencing the Toxicity Table from ISO 10993, there are different tests required for different applications. Th...

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 real...

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 thi...

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 instrum...

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 experien...

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 ...