Signal Management in Medical Device Vigilance: From Complaints and Trends to Risk File Updates and Field Safety Action

The first book on signal management written for medical devices.Device companies receive complaints, code them, decide what is reportable, and file on time. What most of them lack is an owner for the question that connects all of that work: what does this pattern mean, and what must change because of it? Pharmacovigilance answered that question years ago with a named discipline. Device regulation ...