As part of the planning phase, all the tasks for the project are determined and placed in a hierarchical work breakdown structure. The next step is to determine the relationship between the tasks and ...

A major stakeholder in medical devices is the healthcare professional who will be using the device. That’s why as part of design controls, a key initial step is gathering customer needs since they are...

A challenge faced when working in front end research & development is getting a project to charter, particularly, producing a financial model that sponsors can support. Many times the project idea...

Think of it this way - design controls are what you have to do to develop a medical device, project management is how you get it done. Design controls involve key milestones and documentation that nee...

The two go hand in hand to form the final business case that allows the project to be chartered. Marketing will do market research to see what the gaps are in the market, gather data on the target cus...

A project manager's role is challenging because at the end of the project, the PM has to demonstrate how the project succeeded or failed. To determine the project success, the PM has to have set clear...

There are a few communication strategies that can be employed. If sending an email doesn't work, I usually direct message them. If that doesn't work, I put a meeting on that person's calendar. At that...

In this week's simulation, we were given a failed design verification test and tasked with redesigning the test to find out why it failed and how to fix the test. In the scenario given, there was a si...

The previous replies explain the definition of test method validation quite well, but to answer your question simply on the role of TMV in design controls: test methods are developed for two main reas...

Even though the overall structure is similar, in practice, they are executed differently because the actual tests in design verification are completely different that the tests executed for design val...

Design reviews are formal, structured meetings that occur at the end of important design controls milestones (at the end of design input, output, verification, validation, and transfer). To effectivel...

Its true that sometimes it feels like upper management and their timelines are the biggest challenges in a project (and many times that is the actual case), but that is the reality for most large corp...

As discussed in the lecture, a 510k submission for a device can be used if the device is substantially equivalent to a legally marketed device. Once the project team determines to go down this regulat...

First, its important to consider the organizational structure when discussing what skills a certain role needs. In regulatory, there will be a department director that oversees multiple regulatory pro...

The PMBOK Guide introductory chapter stresses the importance of collecting data and information about the project as it progresses such as work performance data, information, and reports. Companies an...