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 which is the Center for Devices and Radiological H...

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 risks, identify actions to prevent them from occu...

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 your customer. A quality plan helps you to schedule a...

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 company to operate at a higher level and less risk...

The difference between the verbal agreements and written agreements is that the written agreement is definitely easier to create, understand, and can be used as a proof to prove to someone or in court...

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 glad I took this course. I found this course help...

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 conference call to share our perspective status of the pr...

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 working with people who you have a better relationship...

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, but one of the particular is that matrix organiz...

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 the goals and context, identify risks, analyzing ...

All risk is valued by Failure Mode Effects and Criticality Analysis (FMECA). It is an approach to analyze risk. Certain factors that contribute to determining the risk values are how something can fai...

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 which stands for Failure Mode Effects and Criticali...

According to FDA, design control makes us demonstrate compliance with codes and it has nine parts. These nine parts are Planning, Input, Output, Review, Verification, Validation, Transfer, Design Chan...

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 Gantt charts. A simple and basic essential you need ...

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 remember what was discussed in the meeting, where di...