I believe the development phase is the most important. By this time most of the groundwork for the project is complete. The planning and design phases are complete, and major project deliverables are ...

As many others have suggested, it is a good start to look at similar products. Even if a true predicate device does not exist, risk strategies can be adopted from other products. The risk analysis pro...

There would have to be something fundamentally wrong with the project in order to go back to a previous phase. The design review process is set up to guide the project forward. Certain requirements mu...

I do not believe that additional approval would be required for a medical device that has already had a PMA. However, all medical device manufacturers are subject to audit from the FDA. Audits can be ...

It is important to understand how you would define underperforming. Is the team member failing to meet deadlines? Are they continuously making mistakes? Are they showing up late often? As a team leade...

I do not necessarily have a preference for a larger or smaller project team. The size of the project team should be determined by the workload needed to complete the project. It is one of the project ...

As a new engineer, I sometimes have trouble assessing priorities for a project I'm not familiar with. Upon becoming familiar with the project, the major milestones needed to complete the project becom...

I have spent my career so far as an engineer only. However, I often think of what attributes my project managers are looking for in me. There are many things that contribute to being a good team membe...

As an engineer, I would prefer a regulatory role in the product development phase. During the development, regulatory must give the engineering team guidance to ensure their activity meets FDA require...

I have used FMEA extensively and consider it to be extremely productive. Specifically, a design FMEA allows the device or part to be analyzed on a feature by feature basis. Each feature is evaluated a...

The fact that the risk management file is a living document is one of the most important aspects of this area. Risk management is a constant cycle of analysis, evaluation, management, and measurement....

I think one of the most interesting risk factors is the probability of a harmful event. The FDA factors the proportion of the intended population that would experience that event and how many times it...

I believe that upper management should have a better idea of the overall function of the company. They should be knowledgeable about the goals and future of the company. It is also important to have s...

FOrming a project team can prove to be difficult but I will share some of my observations. It is sometimes good to form a team which with you have a good relationship. You are aware of the extent of t...

Hello. I am writing this discussion late so I have the benefit of having completed the Medical Device Development Project. I had the role of regulatory and was in charge of completing the regulatory r...