For every medical device, whether it involves risk or not, it needs to be regulated by FDA. And the center that regulates the medical devices is CDRH ...
A risk management plan is a crucial step in a project. It helps to identify risks and implement a plan to reduce them. It helps the members to foresee...
I think quality planning is a critical part of any project in the medical field. It allows an individual to agree on a set of quality targets with you...
Certain companies ask an employee to sign an NDA (non-disclosure agreement) in order to protect their trade secrets. The reason being it allows their ...
The difference between the verbal agreements and written agreements is that the written agreement is definitely easier to create, understand, and can ...
certainly, I agree with most of the participants in this post regarding Dr. Simon’s class. This is my first time taking the class with Dr. Simon. I am...
We had our first meeting on Friday after the initial meeting where we formed a team. We meet every Friday at 7 pm on Google Hangouts through a confere...
I believe in my opinion, the best way to form a project team would be with people who are more knowledgeable in their department role rather than work...
I agree with many of the participants in here, matrix organization would be the best option to start my medical device company. There are many reasons...
There are several approaches used to manage risk in a project as mentioned by many in here. The fundamental steps for risk management are to establish...
All risk is valued by Failure Mode Effects and Criticality Analysis (FMECA). It is an approach to analyze risk. Certain factors that contribute to det...
As it was discussed in the slides by dr.simon, Risk management plan identifies and evaluates all the risk. One method that analyzes risk is by FMECA w...
According to FDA, design control makes us demonstrate compliance with codes and it has nine parts. These nine parts are Planning, Input, Output, Revie...
Regarding the Gantt chart, I have yet to gain experience in the industry, but from my senior year capstone course, I do have experience in creating Ga...
The purpose of doing meeting minutes is to have everyone on the team and everything related to the project straighten out in order. It helps you to re...