A design history file (DHF) is a compilation of documentation that describes the design history of a finished medical device. In my option, The DHF is...

Medical Device: Mitral Clip Definition: Mitral Clip is used to is reduce mitral regurgitation (MR ≥ 3+) due to a primary abnormality of the mitral app...

Clinical data required for premarket approval is a significant difference in time-to-market approval in EU and US. Medical devices in the EU is regula...

I have no experiencing dealing with legal contracts but at Edwards, there is someone from every department assigned to a project; quality, manufacturi...

Multi-center clinical trials are the type of clinical trial that my team at work is trying to get approval for. From my understanding there is no "goo...

I currently work for a group at Edwards Lifesciences that is focusing on a minimally invasive mitral valve repair device. Edwards main goal is to make...

I believe the list of gifts a company can and can’t give is extremely necessary for this day in age where money is very influential. If people are ou...

I would not start any project just based on a verbal agreement. With a written contract you and your team/company have solid evidence about what is ne...

This course was probably the most informative, helpful, realistic course I have taken in the NJIT BME department. I have gone on several interviews th...

I feel like it would be most difficult for a project manager to working in a matrix organization because the main responsibility of the project manage...

I would personally be better suited for upper management. Upper management requires someone that is able to strategies, lead, is financially incline, ...

The main factor when working with people is working with a goal. To form a project team, I would first figure out all details of the project I am work...

AFAP means that the device no longer can be identified with threats towards humans, operational, reputational, procedural, project, financial, technic...

High severity means that the risk occurrence is frequent and is significant and is unacceptable because it has the potential to harm the patient using...

Design review takes place multiple times during the development process and is a milestone in the product development process and the meetings themsel...