Having slack in a project schedule is quite important to ensure that projects have built-in time for unexpected delays without derailing the entire sc...

I agree that schedule risks are often the most prevalent and common in medical device projects, but financial risks are the most devastating. As state...

I agree that a good strategy for accurate cost estimation of a medical device project is to compare to the cost of a similar past project. However, th...

Many of the past responses include questions like what, when, and where. I think these are important questions to ask, and I'd like to add questions a...

Finding a middle-ground to balance innovation and patient safety in medical device development requires a structured yet flexible risk management appr...

Effective risk management in medical device development requires balancing safety, efficiency, and cost. While minimizing risk is essential (especiall...

I agree that real-time monitoring is the best way an organization can create a culture that embraces the PDCA cycle. As mentioned, regularly scheduled...

I agree that it is unwise to jump to design modifications without performing additional tests. It is necessary to pin point where the problem is befor...

I think it could be necessary to vary testing parameters within regulatory guidelines to come to a favorable outcome after failure. Though it may be d...

I agree with the above, well-defined roles are crucial to the long-term success of a project team. It is best to allow group members to define their r...

I agree with what has been said above, that determining specs is an extremely important and delicate part of the design process. The specs must be tig...

I agree that the largest challenge that would come with misclassifying a device is stunting your timeline. Additionally, more resources and a deeper b...

I agree that AI-driven medical devices should be even more highly regulated than other devices because of their potential to evolve over time. I think...

Drugs and medical devices are quite different and their general regulatory pathways reflect those differences. A medical device is some sort of mechan...

I'd also agree that inadequate risk management is the most common regulatory pitfall in medical device development. Classification of the device can b...