Describe your thoughts on what regulations or codes each of the following clinical trials would need to comply with: Central Venous Catheter (CVC) manufactured in the United States and sold only in Eu...

If you have made it this far in the course, you know that GMP's must be implemented, but they are not a set list of requirements. Rather, they are a framework with general requirements. Do you think t...

What happens with projects that are currently being carried out when the Quality System for the company changes drastically? Is there a certain time where a project has just reached a point where it c...

At each stage of the product life cycle, certain aspects are key. For example, in the early stage, Development, it is important to be compliant with FDA and EU regulations but even before that to hav...

Taking the ISO names for these processes: IQ, OQ, PQ, let's look at some devices and summarize what kinds of tests or data you would want to collect to complete each of them. In other words, for each...

What are the FDA and ISO saying in reference to process validation where : "inspection" ≈ "monitoring" and "test" ≈ "measurement" Would IS ultimately still require "full" verification fo...

This module discusses many of the contents of the device master record (DMR), and among those contents were the procedures on post-market surveillance. Post market surveillance is becoming an increas...

There is some reference to this subject in the modules for this course and the Medical Device Development course. One school of thought says that the DHF is sealed at the end of Design Transfer and ne...

Hopefully the difference in these concepts has been solidified through this course and the Medical Device Development course. What are those differences? Now considering this, think about how a Desig...

After this week you should have a basic understanding of how medical devices are regulated and approved in the EU. A lot of people say that it is easier to get devices approved in the EU than in the U...

As an engineer or any professional device person, you need to keep track of the trends in your field. Personally, for me, I tend to have a 30,000 ft view of the entire medical field, so I can give yo...

Well, you did it! You made it to the end of Medical Device Development. The original intent of this course was to teach you what professionals in the medical device field do in the real world if the...

In this module we learned about organization types and how those can affect medical device projects. What type of organization do you work in or what kind would you like to work in and why?

It is important to understand the process of Risk Management which includes Risk Analysis and how this is a living process that flows throughout the entire medical device development process. For mor...

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...