In biomedical device development, I feel like managing scope changes after execution starts can be especially tricky, not just because of timelines an...

This seems like it would be classified as a major change from a project management and regulatory perspective, especially since it affects a functiona...

One area I think could be further explored in managing change fatigue is how we track and reflect on it beyond anecdotal signs. While we often “sense”...

Project execution is inherently dynamic, and adaptability in project management is key to ensuring success, especially in industries like medical devi...

In my experience, ensuring product quality starts well before a device or test reaches the market—QA isn’t just about final products but also about re...

In my experience, the best way to communicate really depends on the size and nature of the team. I worked on a small project with just two or three ot...

Getting a medical device project off the ground is never easy, especially with the many moving parts involved in the initiation phase. One of the bigg...

A well-designed verification protocol is essential for ensuring consistency, reliability, and ultimately the success of a project. One major issue wit...

I definitely agree that emails can be overwhelming, especially when important messages get buried. Setting up filters and scheduling time to check ema...

Gantt charts play a crucial role in medical device project planning by providing structured timelines, tracking dependencies, and managing regulatory ...

Cost estimation in medical device projects is inherently complex due to undefined timelines, evolving regulatory requirements, and unpredictable mater...

As mentioned in the lecture, medical device development projects differ from other areas due to their inherent uncertainties—specifically, undefined t...

Integrating agile methodologies within the design control framework can provide the necessary flexibility to innovate while upholding regulatory compl...

To ensure project success, it's important to implement metrics that evaluate the impact of enterprise environmental factors (EEFs). By developing both...

Enhancing our approach with quantitative risk analysis and metrics is essential. Incorporating numerical methods—such as risk scoring, probability ass...