Design Verification and Design Validation are phases of Design Controls, which used to test the design and ensure that the medical device inputs are match the outputs and the user need. Some cases ade...

A successful validation process for a medical device requires the medical device is typically matching the user needs. In validation, there are some obstacles that may face this process. These obstacl...

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 has been added to the device, and a clinical trial i...

Considering all design development plan (DDP) areas final scope statement, scope management plan, quality management plan, communications management plan, and team member responsibilities have similar...

Design Controls are pre-marketing assaying methods, which were created by FDA in 1996. The design controls duration starts with the project initiation until the final product is tested properly. Desig...

As this week material showing, the design input document (DID) is an overview and short description, and the design specification document (DSD) illustrates a specific technical design data, the selec...

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 important to make policies because those human participan...

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 a good center reputation can affect on the clinic...

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 pharmaceutical drugs the testing has 5 phases from preclinic...

I totally disagree with manipulating customers to influence on their purchases. Marketing is delivering the products or services to the customer. It should be by honest way to get customer loyalty, ly...

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 California interstate 5 highway. The attorney office Super ...

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 sales reports, and some of the decisions depend on th...

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 members. Also, finding someone I trusted today is easy,...

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 business is not die when one of the partners died, so...

As all participants mentioned, the number of people that are going to startup the business shortens the corporations choices like writing off sole proprietorship from choices if more than person are g...