Regarding the points about incentives, I think they can play a role, but they need to be carefully structured. Bonuses work but other things like publ...

One thing I think can be added to this conversatuion is that incorporating regular risk assessments throughout the process is important. As the previo...

From what i've understood, I would emphasize that both processes are crucial in ensuring the safety and efficacy of a medical device, but they operate...

I think the balance between providing access to potentially life-saving treatments and ensuring patient safety is the biiggest challenge with the HDE ...

I agree that the main difference between project and program managers lies in the scope and level of responsibility. The strategic thinking required f...

For smaller, short-term projects where quick decision-making and flexibility are needed, I think a project-based organization works really well becaus...

Good idea to take some time and reflect on what worked with our teams- it was definitely interesting how we all approached problemsolving from differe...

I completely agree with the importance of balancing testing for worst-case scenarios with real-world usage conditions. It’s clear that a product shoul...

Based on the replies on this thread, while the FDA doesn't directly approve the specific procedures for verification and validation, it certainly play...

I don’t have direct/industry experience in this area yet but I think the balance between meeting timelines and ensuring quality is a tough challenge. ...

While I don’t have industry experience yet I can see how EEFS would play a significant role in project delays, especiallywith external factors like su...

Iff we had the option to modify the DSD, the approach would shift for sure. I do think that changing the verification test alone is a more straightfor...

Having a clear plan in place definitely seems like a responsible step for any business owner to ensure smooth operations during unexpected situations....

These are all really good insights, it makes sense that having clear deliverables and timelines in agreements would help avoid confusion. I also like ...

In medical device consulting agreements, arbitration and mediation are common because they’re quicker and less expensive than litigation. Setting clea...