As Dev said, there should be multiple design review meetings and controls such that there is no need to return to a completed phase. If a PM and their...

I think that certifications without the degree to back them up don't really mean anything in an industry setting, whereas someone with a degree (say a...

I agree with Krish that the PM's role combines task management with the objective of completing the DHF and compliance assurance. While the PM shouldn...

I agree with Ehab that changing the DSD may not be necessary in this case due to the nature of its stipulations not including that the water bath had ...

If the stents fail during in-vivo testing, the team as an entirety would need to re-assess the design. It would be critical to understand why the sten...

Products like smartphones or less-strictly-regulated medical devices, such as Class I devices, can have a very fast product life cycle. I have seen th...

I agree with Sami that collaboration is a big component in ensuring a full completion of the DHF, especially when the design controls and project mana...

In order to make sure important information isn't overlooked in the DHF creation process, it is important to be constantly working on the document rat...

I think that a crucial part of a PM's job post-market release is ensuring that all the proper documentation has been collected and organized, and the ...

I also agree with Vansh that it would be more under the purview of a regulatory control team member than the PM to ensure that FDA regulations are bei...

I think that the answer to this is very situational. If, as a PM, you anticipate being in charge of a very niche biomedical product, and future projec...

I think to be a successful project manager relies heavily on the interpersonal skills. If you have established respect and a rapport with your team, y...