Many of the previous replies to this thread summarize the overall theme of submission of fraudulent 510ks and have gone through the steps on why it wo...

There is no avoiding initial mistakes in a project team. Its part of the growing pains that occur with newer teams and project managers. That being sa...

This answer sums up a competitive business model to help fill in gaps in a product portfolio. Project initiation should begin prior to the approval st...

I think project management in the medical device industry does not necessarily make one an expert in being a project manager in other industries. The ...

I have actually found Covid-19 to disrupt project management in a different way than just being virtual at all times. Since many companies had feared ...

Earnestly, this ultimately depends on the role you have as an engineer in your respective company. If you solely are performing validations of softwar...

@jmeghai I agree that there should be a thought on verification in the early stages of development, but I don't agree that products should be verifi...

I work at Stryker currently where I mechanically evaluate the implants and instruments created by research and development as well as develop supporti...