In the article, FDA: Toxic Belladonna In Homeopathic Teething Product, the FDA found that Hyland’s homeopathic teething products had belladonna, which is a toxic chemical, a level far exceeding the am...

From this week’s lecture, there are multiple steps in a project cycle. Describe a time when you took part in a project in industry or in school. What design controls did you take part in the project? ...

From the lecture, there are 9 parts to design controls. Why is initiating a project idea the hardest part of project development? How does business and market research play an important role when init...

The necessary regulation to get FDA approval of a combination product is first the company has to request for designation (RFD), in which companies have to outline the rationale of the product. Then, ...

A Brooklyn startup company, Modern Meadows, has a technique to develop meat without killing any animals. The process they use to make this meat is by incorporating fetal bovine serum, which is the blo...

When you open your Google play store or Apple Store, you can find an app for everything, even things related for medical purposes, such as an app that measures blood pressure. Moreover, the FDA has re...

One of the critiques the IOM said about the 510 (K) process was that it lacked the legal basis to be reliable of the safety and effectiveness of moderate -risk class II devices. The reason why the 510...

The kind of organization I feel that I would be most suited for is project-based one, which an organizational structure when a company’s department and personnel are organized around a particular proj...

I think project management differs in different industries is in terms of regulations involved on a project. For instance, projects in the biomedical industries need to take into consideration the FDA...