Posted by: @orleron As you interact with the CRA profession, you will notice a heavy preference for people with a “clinical background”. This means people who have been or are nurses, doctors, or other kinds of technical workers who interact…   Read more»

Posted by: @orleron Remember “The Four Ps of Marketing”: product, price, promotion, and placement. Product:What are you selling & why?Price:How much does the product cost? When does the price change?Promotion:How will you promote the product? Viral marketing? Internet Advertising?Placement:Who sells…   Read more»

Posted by: @orleron This is always a fun module for discussion topics because there’s always some modern technology out there that challenges the current regulatory framework. Today… e-cigarettes. If you don’t know what one is, google it. Does the FDA…   Read more»

Posted by: @orleron Explain the difference between QA and QC, and think about the differences that each of these have as a career.  For example: What types of training are relevant to each and how could they differ? What types…   Read more»

Posted by: @orleron This week is an overall introduction to the field of medical device development. We take some time to pay attention to the differences between Academia and Industry (Commercial) because students in this course may come from one…   Read more»

Posted by: @orleron This week is an overall introduction to the field of medical device development. We take some time to pay attention to the differences between Academia and Industry (Commercial) because students in this course may come from one…   Read more»

Posted by: @orleron We are meeting in an interesting time, to say the least.  As a disease, covid19 has many elements to its treatment and many of those elements use medical devices.  There are ventilators and syringes, which we all…   Read more»

Posted by: @orleron Project Initiation requires several things, as per the lecture, and two of them are enterprise environmental factors and organizational process assets. Give some examples of each as they appear in your organization where you work. How would…   Read more»

Posted by: @orleron If you currently work in Industry, tell us what kind of organization you work with, i.e. whether it is a functional, matrix, or project-based one. If you do not work in Industry yet, tell us what kind…   Read more»

Posted by: @orleron One “fun” thing to talk about during the Regulatory lectures is the ongoing soap opera of what is happening to the 510(k) process. One of the key events in the saga was a controversial report issued by…   Read more»

Posted by: @orleron How do you think Project Management differs in different industries or different types of Project? If you are a great PM for doing Medical Device Projects, does that mean I can throw you into a software company…   Read more»

Posted by: @orleron We have begun learning about the Design History File (DHF) this module. We are more than halfway through the course, so congrats for making it this far! This module deals with the DHF contents and how to…   Read more»

Posted by: @orleron Being able to look at the financial statements of a company and determine some guesses on its health is a good skill to have. All public companies in the US must publish their financial statements quarterly and…   Read more»

Posted by: @orleron We are meeting in an interesting time, to say the least.  As a disease, covid19 has many elements to its treatment and many of those elements use medical devices.  There are ventilators and syringes, which we all…   Read more»

Posted by: @orleron This is a phrase you will encounter sometimes. “The Cost of Quality” is a concept. Let’s say you have a product, and you do no QA/QC on it. For a while, you might do fine. The product…   Read more»

Posted by: @orleron This is always a fun module for discussion topics because there’s always some modern technology out there that challenges the current regulatory framework. Today… e-cigarettes. If you don’t know what one is, google it. Does the FDA…   Read more»

Posted by: @orleron Explain the difference between QA and QC, and think about the differences that each of these have as a career.  For example: What types of training are relevant to each and how could they differ? What types…   Read more»

Posted by: @orleron Up until now we have talked about two big topics:  project management and pre-clinical research.  There are some other discussions in this forum about biomaterial selection for scientific and safety purposes, but I want now to talk…   Read more»

Posted by: @orleron This week is an overall introduction to the field of medical device development. We take some time to pay attention to the differences between Academia and Industry (Commercial) because students in this course may come from one…   Read more»

Posted by: @orleron Explain the difference between QA and QC, and think about the differences that each of these have as a career.  For example:What types of training are relevant to each and how could they differ?What types of jobs…   Read more»