Quality Assurance is a way of preventing mistakes and issues within manufacturing environments. Describe ways to prevent and ensure manufacturing safety. In addition look up a issue that has happened ...

The FDA has created many regulation agencies to monitor medical devices, biologics , and drugs. CDRH: Reviews and approves medical devices •CDER: Reviews and approves prescription, OTC, and generic dr...

In the PowerPoint discussion regulatory basis for medical devices it described how the tetanus Tetanus outbreak traced to diptheria antitoxin was the reason the FDA fully intervened and began this in...

Animal testing is essential in scientific research because it seeks to analyze the variables that affect behavior or biological system under a study. The main pitfall in animal testing is suppliers ru...

Stability Testing is an essential process for each component of a medical device. It determines how long a product remains safe and effective at specific intervals. After multiple runs of testing is c...

This week we learned about the importance of biocompatibility testing and how this testing assess the compatibility of medical devices with a biological system. This test must be done for a material o...

Project management is the basis of getting things done. They lead and guide a team’s work to create a successful project and reach designed goals. There are additional certificates you can obtain to b...

A person working in an academic institution usually title as a post-doctoral researcher, Associate Professor, or Development Engineer. These people share their knowledge and solve problems with other ...

Project stakeholders are the components that has an interest in a projects outcome. This refers to an individual, group, or organization that contributes to the project and can have an affect from the...

The project life cycle consists of many steps; Initiating, Planning, Executing, and Closing, while monitoring and controlling throughout. I would like to know which step is most important to you. Some...

Regulatory Affairs is a industry that ensures the safety of the public when overseeing food, medical products, and drugs. This management make sure companies making medical devices comply with FDA reg...

When being introduced to academia and industry medical device development we see pros and cons to both pathways depending on your interest. Professions in academia focuses more on conducting research ...