When it comes to project team , skills and experiences are keys for a successful project. I would really like to be a leader and or show my experience...

A 510(k) contains detailed technical, safety, and performance information about a medical device. The documentation must demonstrate the device in que...

Always allow people to come to you. Be accessible and listen to what project team members will ask or comment all the time. The more you know, the bet...

The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of software applications (apps) and mobile a...

A risk management file (RMF) is the place where you keep your risk management activities, documentation, and records. A risk management file contains...

When dealing with risk , the only time we can accept the risk is before the clinical trial . We want to maximize the revenues and minimize the risks f...

On my personal experience, the brainstorming , FMEA and Fish borne diagram are all important but To begin the brainstorming process, you must assess t...

I personally won't accept job based on company . I want to get my feet wet first . But they are few stuffs to consider. I want to be certain about my ...

The minutes for meetings very important moment during decision making. It’s important that the right person take notes because the note-taker must be ...

The imoprtant parts of DDP are The purpose of the design and development plan section is to provide investors with a description of the product's desi...

Yes. it is important that you design and develop a medical device that is safe. FDA and EU and all other regulatory bodies throughout the world will w...

I will prefer to be in a partnership with the owner. not bad ideas . all my job will be based on investments in a very clever way. I might not have a ...