Design verification involves confirming that the design output meets the design input requirements (i.e. dimensions). Design validation ensures that devices conform to defined user needs (i.e. portabl...

As per the responses from my peers it is more favorable to perform a double-blinded study over a single-blinded study in order to reduce intentional or inadvertent biases such as from the placebo effe...

Whether or not a clinical trial proceeds is not just based on if the sponsors and investigators can get the informed consent of individuals enrolled in their study but the study must be reviewed, appr...

Upon reviewing responses from my peers, I have to agree with all the pros and cons that have been outlined, however, I wanted to bring some clarity to the discussion. There are different types of clin...

I have to agree with my peers. No matter what type of business we are talking about, whether a start-up or corporation - all marketing considerations and decisions are typically formed around the prod...

In the medtech start-up space, participation is probably the most important piece of the puzzle given how imperative it is to engage with early adopters. Unlike with existing and established companies...

After reviewing my peer's post I found no one posted about Abbott's mission and vision statements. Mission Statement: "Live your best life, now and in the future." [] Vision Statement: "At Abbott, we...

As per this weeks lecture, some clear advantages of a C-Corp over an S-Corp include that there are no restrictions as to the country of origin from which the shareholders must be, the corporation can ...

An LLC or a limited liability corporation is a structured business entity that helps shield owners, who are usually founders/members, from litigation. An Inc. or corporation, such as an S-Corp and C-C...

I first gained exposure to principles of business through an introduction to business management course that I took during undergrad. Since then I went on to learn about entrepreneurship through the N...

As per this week's lecture, QA is preventative in nature meaning it is a proactive approach to identifying issues in a process that prevent a product or service from meeting user and/or regulatory req...

The example Dr. Simon shared truly reflects the importance of QA/QC. Given I work as a clinical engineer who provides imaging services, I would like to share another perspective - this time on the imp...

My experience in quality assurance stems from working as a clinical engineer who provides imaging services across a healthcare system. My job focuses on taking a proactive approach to maintain high qu...

I agree with knm7, but it is important to mention that the FDA determines its' classifications based on factors such as indications for use (see example: which means that the product should have a la...

Like most of my peers I have not had a regulatory role and prefer to be able to utilize my engineering background, however, being a successful engineer requires an understanding of good manufacturing ...