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 public recognition or additional responsibility might ...

One thing I think can be added to this conversatuion is that incorporating regular risk assessments throughout the process is important. As the previous reply mentioned, using a risk register can be a...

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 in different contexts. Verification focuses more ...

I think the balance between providing access to potentially life-saving treatments and ensuring patient safety is the biiggest challenge with the HDE program. While it’s undeniable that HDE facilitate...

I agree that the main difference between project and program managers lies in the scope and level of responsibility. The strategic thinking required for program managers makes their role a bit more co...

For smaller, short-term projects where quick decision-making and flexibility are needed, I think a project-based organization works really well because it allows the team to focus solely on the task a...

Good idea to take some time and reflect on what worked with our teams- it was definitely interesting how we all approached problemsolving from different angles. In my team, I took the lead on organizi...

I completely agree with the importance of balancing testing for worst-case scenarios with real-world usage conditions. It’s clear that a product should be able to withstand extreme conditions that may...

Based on the replies on this thread, while the FDA doesn't directly approve the specific procedures for verification and validation, it certainly plays a critical role in ensuring that the end results...

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. Because, its clear from the discussion that the FD...

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 supply chain issues or internal factors like organiz...

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 straightforward and cost-effective route, but altering the DS...

Having a clear plan in place definitely seems like a responsible step for any business owner to ensure smooth operations during unexpected situations. Without something mapped out, I can imagine it wo...

These are all really good insights, it makes sense that having clear deliverables and timelines in agreements would help avoid confusion. I also like the idea of adding periodic reviews to keep things...

In medical device consulting agreements, arbitration and mediation are common because they’re quicker and less expensive than litigation. Setting clear jurisdiction clauses or using neutral venues can...