The "Capacity" aspect of contract law basically means that the parties signing to the contract must all have the appropriate 1) authorities, and 2) mental capabilities to take on the responsibility of...

@kaf43 A recent example I could find of kickback allegations is with the medical device manufacturer Biotronik Inc. This company is a privately-owned partnership that manufactures various types of car...

As someone who started working in industry before attending graduate school, I really wish I had something like this course during undergrad! I really had no idea as an undergrad what the day-to-day w...

The company I currently work for can best be described as a matrix organization. We have clearly defined departments that are organized by function, and projects span across the multiple departments. ...

Compared to functional or project-based organizations, matrix organizations can be the best of both worlds in terms of efficiently managing resources between both day-to-day activities and projects. H...

In my experience I've mostly seen Gantt charts being used to plan out projects, but I think a network diagram could be a useful tool as well, since they can each serve different purposes. Gantt charts...

I currently work at a medical device company, and risk assessment does show up everywhere, even if it's not a full-fledged risk analysis for a new product design. For instance, if there is a nonconfor...

Figuring out the probability and severity of the product's risks (AKA Risk Evaluation) is another way to tell whether the risks are worth the benefits. Even if you have some risks that occur frequentl...

I think risk management is the most critical when designing the product, because as discussed in lecture, the most effective way to manage risk is to design it out. Designing the risk out of the devic...

The company I work for mainly specializes in devices related to cardiovascular surgery, but I found out that a while ago there was actually a project proposed for a device that would be used in surger...

I think that an important thing to consider when creating the project Gantt chart is to not divide your tasks into too many subtasks, especially for a project spanning a long period of time. Doing thi...

To answer on how test method validation relates to design controls, at my company we use a document called a Master Validation Plan (MVP). Basically, the MVP contains a table listing out all the diffe...

This is a good question, there are many factors that come into play that determine how regulatory standards are actually put into practice. I think a major one is how much time the team has to complet...

The Design Controls process requires collaboration from essentially every department in the medical device company to ensure all stages of the product are designed with the best quality possible. But ...

Another important aspect to consider when developing verification tests is your sample size. Say there are 100 pieces of a component per lot, and you need to verify the component can withstand a certa...