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 stents are failing and possible avenues to rectify tha...

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 that Class II and III products tend to have a longer...

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 management processes are separated. If the two are com...

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 rather than waiting for the end. It also would likely...

Especially for Class II and III devices, the pathway to FDA approval can take many years and a sizeable budget. As a PM, what are ways that you can ensure the project is following the intended timelin...

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 PM should, as Sami mentioned, either prepare for p...

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 being upheld, but I believe that a close relationship...

As discussed in other posts, a project manager's interpersonal skills are quite important for the role, and project managers may not possess all of the technical expertise of their team members. In a ...

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 projects you manage will also remain in that niche, it w...

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, you would, in theory, be able to rely on them when ...