Basically significant risk devices are to be use in supporting human life and present a potential risk to the patient's health. The potential harm to subjects could be life-threatening, could result i...

What do you think is the difference between a project manager and a clinical project manager

Design validation ensures that devices conform to defined user needs and the intended use stated in the design input. I believe a diagnostic microscope has no risk on people therefore there is no need...

I work in a matrix organization, where employees may report to many managers, for example in my case I work as design engineer in a functional department sometimes the company gets a project that need...

I work for a class I and II medical device company that carries out development, manufacturing and marketing of implant-based dental restorations. Unfortunately we do not have a well developed project...

What do you think is one skill a project manager needs to succeed?