mejefferson

Forum Replies Created

RE: Precision and Accuracy

Posted by: @sahitya-sadineni Precision and accuracy are very important to the scientific field. Accuracy is how close the value is to a standard while precision refers to how close the values are. Wh...

In forum Regulatory Basics for Medical Devices

4 years ago
RE: Issues with the Quality Department

Posted by: @bb254 Based on your work experience in any company, what were some issues you found with the quality department and how would you fix them? For example:I work in the manufacturing departm...

In forum Quality Control and Quality Assurance

4 years ago
The Timing of Approving Medical Devices

The average medical device takes years to receive approval from the Food and Drug Administration. Devices have to go through many stages such as investigational device exemption, premarket notificatio...

In forum Regulatory Basics for Medical Devices

4 years ago
RE: Talking about animal research

Posted by: @tulikadasp When it comes to animal research there are various constraints we need to keep in mind. One of them is animal rights. A lot of animal rights group are against this. Recently th...

In forum Pre-clinical Device Development

4 years ago
RE: Failure's of Pre-Clinical / Clinical Research

Posted by: @savery115 I've never had the opportunity to conduct or be a part of a team doing pre-clinical / clinical research. For those of you who have done it in the past or are currently working i...

In forum Pre-clinical Device Development

4 years ago
RE: This vs That

Posted by: @manolo In week one, Dr. Simon went over different aspects of working in Academia vs Industry. He asked us to make an argument for working in either option. As we start going into each rol...

In forum Pre-clinical Device Development

4 years ago
RE: Discussion Topic: Practical vs. Informational courses

Posted by: @orleron As I said in the lecture for this module, this course is different. Whereas most courses seek to fill you with academic information in order to create a knowledge base for yoursel...

In forum Introduction to Medical Device Development

4 years ago
Medical Device Certification

The medical device development process requires specific stages to be followed to ensure design control so that the product is both effective and safe for use. As a result, this covers the entire prod...

In forum Introduction to Medical Device Development

4 years ago
RE: Human resource management

Posted by: @ka-kyung-kim I have one scenario I wonder about what happens in this caseIn human resource management, a team has been settled and worked on a project and in the middle of the process. Th...

In forum Project Management Knowledge Areas

4 years ago
RE: QA vs QC

Posted by: @aasutosh-purohit In the lecture we studied about Quality Assurance and Quality control. How these both are different from each other? There are many differences between quality control a...

In forum Project Management Knowledge Areas

4 years ago
Potential PM?

From all of the knowledge we have gained throughout PMP, from the basics, to the project life cycle and organizations, to breaking down each process, down to managing a project, do you think you have ...

In forum Project Management Knowledge Areas

4 years ago
From a Stakeholders Point of View

Stakeholders typically invest in projects that they see will have potential in bringing more money than they invest in. Outside of monitoring the finances throughout the project, do you think stakehol...

In forum Project Management Process and Medical Device Development

4 years ago
RE: Best Processes/ Phase

In my opinion, every process involved in project management, from the initiation phase to the closing phase is just as equally important as the other. During initiation, you are trying to turn an idea...

In forum Project Management Process and Medical Device Development

4 years ago
RE: Monitoring & Controlling Techniques

Although every technique in the monitoring and controlling phase is important, I believe that the approval or rejection change makes or breaks the project. Suppose a PM approves of a medical device th...

In forum Project Management Process and Medical Device Development

4 years ago
RE: Source Selection in Executing Process

Posted by: @rgp29 In this week’s lecture Dr. Simon mentioned that during the executing process of a project, the project manager (PM) is in charge of the source selection. This means the PM must deci...

In forum Project Management Process and Medical Device Development

4 years ago
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