Forum Replies Created
RE: Written Agreement v/s Verbal Agreement I agree that written agreements are preferred over verbal agreements, especially when it comes to legal disputes in court. However, possible advantages to verbal agreements include ease, convenience, ... |
In forum Consultants and Legal Basics |
4 years ago |
RE: Recent Examples of Kickback Allegations An example of a recent kickback is in October 2020, when Medtronic agreed to pay neurosurgeon Dr. Wilson Asfora for social events at a restaurant which he owned. Dr. Asfora would also have social gath... |
In forum Consultants and Legal Basics |
4 years ago |
RE: Discussion Topic: Course conclusion and impressions I really liked the practicality of the information taught in this class. For those wanting to work in the medical device industry (or already do), this course teaches each step of medical device devel... |
In forum Consultants and Legal Basics |
4 years ago |
RE: Traits of upper management versus middle management Upper management and middle management also differ in their vision, with the former being more long-term focused and the latter being more short-term focused. Both share effective leadership qualities... |
4 years ago | |
RE: Organization Type vs. Effectiveness I don't think there is one best and most effective organizational structure for a company, but there is a particular organizational structure that works best for an employee at the company. Some may a... |
4 years ago | |
RE: Discussion Topic: Your organizational type I would like to work in a matrix type organization, because it seems to be highly efficient, i.e. there are no departmental silos nor are there redundant resources, and knowledge transfers well from p... |
4 years ago | |
RE: Factors Contributing to Risk Values Another factor contributing to risk values is the percentage of false-positives or false negatives, particularly for diagnostic devices. For example, if a patient is scanned (with X-ray, MRI, ultrasou... |
In forum Risk Analysis for Medical Devices |
4 years ago |
RE: Dealing with risk A Risk Matrix can also be used to assess risk and see whether or not the risk should be accepted. For a medical device with high severity of risk, it may be acceptable if the occurrence is occasional,... |
In forum Risk Analysis for Medical Devices |
4 years ago |
RE: Risk management methods Another risk management method is Root Cause Analysis (RCA), which gets to the main reason for risk. It identifies the fundamental risks involved in a project, usually after the problem has come up. R... |
In forum Risk Analysis for Medical Devices |
4 years ago |
RE: Factors to Consider While making Gantt Chart This might sound a bit silly, but I think one factor to consider is whether one needs a Gantt Chart in the first place. For my capstone project, we used a simple project timeline along with weekly to-... |
In forum Introduction to Design Controls |
4 years ago |
RE: Statistical Sampling In a research lab setting, we commonly look at previous studies that would be similar to our proposed study and calculate the effect size for that study (which is sometimes directly stated in the rese... |
In forum Introduction to Design Controls |
4 years ago |
RE: Minutes for meetings Meeting minutes are especially important for those working on multiple projects, since each project has its own set of tasks and someone may easily confuse or forget those tasks. It also helps the tea... |
In forum Introduction to Design Controls |
4 years ago |
RE: Consequences Of Insufficient Design Controls It is difficult to exactly pinpoint the issues that arise from insufficient design controls, since the process of design controls has 9 parts within it: planning, input, output, review, verification, ... |
In forum Introduction to Design Controls |
4 years ago |
RE: Design Transfer A risk vs. benefit analysis can also be done to decide whether one should outsource or perform in-house production. With in-house production, one may face risks with money, especially for smaller comp... |
In forum Introduction to Design Controls |
4 years ago |
RE: Making up tests for design verification and validation Another way to choose which test to perform is to look at previous studies' design specifications and question how they obtained those specifications. For my senior capstone project, we did a lot of r... |
In forum Introduction to Design Controls |
4 years ago |