Last seen: Dec 4, 2022
The "Capacity" aspect of contract law basically means that the parties signing to the contract must all have the appropriate 1) authorities, and 2) me...
@kaf43 A recent example I could find of kickback allegations is with the medical device manufacturer Biotronik Inc. This company is a privately-owned...
As someone who started working in industry before attending graduate school, I really wish I had something like this course during undergrad! I really...
The company I currently work for can best be described as a matrix organization. We have clearly defined departments that are organized by function, a...
Compared to functional or project-based organizations, matrix organizations can be the best of both worlds in terms of efficiently managing resources ...
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 th...
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 pro...
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...
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 ...
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 ...
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...
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, ...
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 ...
The Design Controls process requires collaboration from essentially every department in the medical device company to ensure all stages of the product...
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 ...