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 in permanent impairment of a body function or permanent damage to the body structure. for example dental implants which required clinical trials. In…[Read more]

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 for clinical trial. An implantable bone plate is considered class III medical device meaning highly risk for patients so we must perform clinical…[Read more]

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 needs a design engineer to assist the “project manager” (senior process Engineer because we do not have PMs) on certain tasks. I may be assigned to the…[Read more]

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 management system, in other words we don’t have project managers, usually senior process engineers take the role and run the projects, to keep track…[Read more]