I agree with the standpoint on how a DHF should be an evolving document. It is also crucial to take into consideration that a DHF is not only an evolv...

From the responses, I see that many focus on the significance of the Check and Act phases of the PDCA cycle, which is valid. However, I would like to ...

Regulatory and post market efforts are essential to a medical device's product life cycle. I would like to add onto what Ehab mentioned; another point...

Building off of what Ehab mentioned as to how PM should have an understanding of FDA requirements and maintain involvement in project development. It ...

One perspective that can contribute to meeting deadlines is utilizing a decision based milestone plan tied to FDA risk thresholds with a range in time...

Once a product is in the post-market phase, a project manager's role changes from developing to ensuring that the product maintains continuity, which ...

Interpersonal skills are essential to PM than technical skills as a Vansh Amin points out and are required for facilitating collaboration. However, fo...

I've encountered situations where there was friction between problem-solving initiatives. An effective approach that can be considered is utilizing a ...

Although it can be agreed upon that most project managers are not required to have a deep level of understanding in technical projects and their exper...