Design Verification and Design Validation are phases of Design Controls, which used to test the design and ensure that the medical device inputs are m...

A successful validation process for a medical device requires the medical device is typically matching the user needs. In validation, there are some o...

In medical devices, validation is generally important to make ensure that the intended usages of a device are safe, if there is an update or change ha...

Considering all design development plan (DDP) areas final scope statement, scope management plan, quality management plan, communications management p...

Design Controls are pre-marketing assaying methods, which were created by FDA in 1996. The design controls duration starts with the project initiation...

As this week material showing, the design input document (DID) is an overview and short description, and the design specification document (DSD) illus...

When it comes to clinical research ethics is a critical point to make sure research participants are safe and their rights are protected. It’s importa...

The triple blind study is the more accurate in terms of bias elimination. Also, as professor Simon said in the lecture, the good Doctor of Medicine or...

In my opinion clinical trials doesn’t differ either testing a drug or a device it is a way of improving the overall wellbeing of humans. In pharmaceut...

I totally disagree with manipulating customers to influence on their purchases. Marketing is delivering the products or services to the customer. It s...

According to me, I saw a lot of advertisements that are wonderful, but the advertisement that is stuck on my mind is a lawyer advertising on Californi...

In my opinion, sales and product management need to exchange their data or at least some of the data. Many of product management decisions rely on sal...

Since the partnership corporation can pursue my personal finance, I personally think it is not save at all even if my partner were one of family membe...

Since I want to avoid the responsibility of running a company, I would want to be a silent partner in a Limited Liability Company (LLC). Also, the bus...

As all participants mentioned, the number of people that are going to startup the business shortens the corporations choices like writing off sole pro...