Posted by: @as934 While consultants can provide many different areas of expertise, the consultants that I have come across during my career in the medical device industry have mostly been experts in ...

Posted by: @rgp29 Hello everyone, As I was listening to this week's lecture, it called my attention the fact that companies can only give gifts of 100$ to the physicians and those gifts have to be re...

Posted by: @fo3 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project ac...

Posted by: @hg93 Risk management is the process of analyzing, identifying and responding to risk factors throughout the course of the project. Managing risks early on in the project is the best way t...

Posted by: @smk45 I came across an article online that highlights 4 reasons why a company's risk management approach may be wrong. It was an interesting read and indicates the following as major erro...

A risk management file accumulates all the records, files/documents, and activity logs pertaining to risk management. According to greenlight guru, a risk management file can include all of the follow...

Posted by: @rgp29 Hello everyone, I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Bef...

In response to prevent so many recalls of medical devices and other medical products, the FDA envokes design controls regulations. Design controls are a set of policies and procedures implemented to s...

In the US, the FDA regulates and implements design controls. However, there are similar governing bodies and procedures in other countries. For example, in China, there is the Chinese Food and Drug Ad...

Posted by: @orleron As you interact with the CRA profession, you will notice a heavy preference for people with a "clinical background". This means people who have been or are nurses, doctors, or oth...

Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or someti...

Posted by: @savery115 Clinical trials and research is designed to expose a limited sample of subjects to potential new treatments. Human tests of a medical intervention typically pose risk to subject...

Posted by: @manolo Dr. Simon touched upon Branding when going over the Facets of Marketing. The coloring is an important component to think about when branding a product/company. What kind of colorin...

@as934 The use of social media to create an interactive platform is increasingly becoming common practice to utilize social media for marketing and increase possible consumers' participation. Especial...

Posted by: @orleron Remember “The Four Ps of Marketing”: product, price, promotion, and placement. Product:What are you selling & why?Price:How much does the product cost? When does the price cha...