Forum

nm523@njit.edu
@nm523njit-edu
Trusted Member
Joined: Sep 3, 2021
Last seen: Mar 24, 2024
Topics: 9 / Replies: 56
Reply
RE: Leaders of Change Control

Most larger medical device companies have developed an 'Approval Matrix' that details out every potential type of change and document category (ex. ch...

4 days ago
Reply
RE: Monitoring and Controlling in a Project

An important aspect of a project to monitor is project risk. At the start of the project a risk register is created with the potential risks, severity...

4 days ago
Reply
RE: Compromises in Conflict

There are many strategies to try to resolve the conflict and discrepancies in understanding between the project lead and upper management, as describe...

3 weeks ago
Reply
RE: Examples of when Design Validation is Not Required

Validation is not required when the customer need is self evident. For example, if the customer need is for a sterile device, no validation test is re...

3 weeks ago
Reply
RE: Email Communication

As @shahil mentioned, setting up rules in your email to sort is a great tool for keeping your email organized. There are a few ways to do this:creatin...

3 weeks ago
Reply
RE: Planning and Executing in Project Management

@torikul Agree with all the above but especially wanted to highlight your point about running pilot studies. As a working engineer, I have seen projec...

4 weeks ago
Reply
RE: Making connections between people and schools

Hi everyone! My name is Nora Moustafa and I am an R&D Engineer at Ethicon, Johnson & Johnson. Looking forward to connecting:/p>

1 month ago
Reply
RE: Who is a Stakeholder?

A major stakeholder in medical devices is the healthcare professional who will be using the device. That’s why as part of design controls, a key initi...

1 month ago
Reply
RE: What is the difference between project management process and design control?

Think of it this way - design controls are what you have to do to develop a medical device, project management is how you get it done. Design controls...

1 month ago
Reply
RE: Feasibility Research vs Marketing Research

The two go hand in hand to form the final business case that allows the project to be chartered. Marketing will do market research to see what the gap...

1 month ago
Topic
Page 1 / 5