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 regulatory compliance. Companies may hire compliance consultants to…   Read more»

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 related to health. Additionally,…   Read more»

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 according to their expertise/role. How would…   Read more»

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 to avoid project catastrophes. Continuously applying the…   Read more»

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 errors: 1. Risk management and design controls…   Read more»

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 following: Risk Management Plan Risk Analysis Risk Evaluation Risk Controls Evaluation…   Read more»

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. Before this, when I was…   Read more»

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 standardized quality checks points of medical devices. They control…   Read more»

Design controls are a set of policies and procedures implemented to standardized quality checks points of medical devices. They control the design process to ensure that a medical device meets specific requirements that are helpful to the consumer. In general,…   Read more»

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 other kinds of technical workers who interact…   Read more»

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 sometimes called a ‘sugar pill. Or a fake…   Read more»

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 subjects despite the amount of laboratory and pre-clinical trails conducted…   Read more»

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 coloring do you notice companies are using and why…   Read more»

@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. Especially more prevalent with quarantine and COVID restrictions. I have not personally seen…   Read more»

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 change?Promotion:How will you promote the product? Viral marketing? Internet Advertising?Placement:Who sells…   Read more»

Posted by: @orleron This is always a fun module for discussion topics because there’s always some modern technology out there that challenges the current regulatory framework. Today… e-cigarettes. If you don’t know what one is, google it. Does the FDA…   Read more»

@jafar When I thought about this question I immediately thought about the difference in drug regulation between the US and India. The US is known for having one of the most organized and regulated drugs governing bodies while India is…   Read more»

Posted by: @sahitya-sadineni Part of FDA’s mission statement is providing safety and protecting the public health in the use of drugs, medical devices, and etc.. The second part of the mission statement states that they are “advancing the public health…   Read more»

Posted by: @sahitya-sadineni Part of FDA’s mission statement is providing safety and protecting the public health in the use of drugs, medical devices, and etc.. The second part of the mission statement states that they are “advancing the public health…   Read more»

Posted by: @mrlee5 There are scientists who are developing and using animal-free methods that are actually shown to be relevant to human health for studying diseases and testing products. There is a variety of cell-based tests and tissue models that…   Read more»