Last seen: Mar 24, 2024
Most larger medical device companies have developed an 'Approval Matrix' that details out every potential type of change and document category (ex. ch...
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...
There are many strategies to try to resolve the conflict and discrepancies in understanding between the project lead and upper management, as describe...
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...
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...
@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...
Hi everyone! My name is Nora Moustafa and I am an R&D Engineer at Ethicon, Johnson & Johnson. Looking forward to connecting:/p>
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...
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...
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...