Hafez Selim
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 never did. EU MDR Article 88 asks for trend reports, ISO 14971 asks for post-production information to flow into the risk file, and ISO 13485 asks for complaints to be investigated, but none of them tells a vigilance specialist how to recognize that three fractures at a new location matter more than ninety cosmetic complaints, or how to defend a decision not to act when an auditor reads the record two years later.This book fills that gap. In 28 chapters it follows a signal from the first complaint to the closed record: detection across complaints, returned devices, registries, clinical follow-up and device telemetry; control charts, CUSUM and Article 88 thresholds; disproportionality and registry outlier methods; time-to-failure and survival analysis; validation, prioritization and the written assessment question; case series and returned-device investigation; root cause across design, manufacturing, use and patient; integrated assessment and causality; the ISO 14971 risk file update; the action ladder from monitoring to field safety corrective action; benefit-risk; field safety notices; review boards, documentation, audits and metrics; and the place of AI and real-world data.Eight fictional devices carry the argument with fixed numbers that match across every chapter: a hip implant, an antibiotic-loaded bone void filler, an insulin pump, an infusion pump, a defibrillator lead, an AI triage tool, a surgical stapler and a central venous catheter. Every chapter ends with a one-page Bottom Line, five knowledge-check questions and an applied exercise, with full answers. A companion website provides 24 editable toolkit files, six calculators and an interactive Case Lab that runs all eight cases through the ten-step process.Written for manufacturer vigilance and post-market surveillance specialists, complaint-handling leads, safety physicians, risk management engineers, quality and CAPA owners, and regulatory affairs professionals. Companion to Signal Management in Pharmacovigilance by the same author.Dr. Hafez Selim, MD, PhD, is a physician-scientist who has worked on both sides of product safety. For nearly a decade he was medical advisor and safety physician in the spine division of a global medical device company, with safety leadership for combination-product clinical trials and oversight of a spinal implant portfolio, and he obtained the first 510(k) clearance for PEEK rods. He now works across drug safety and clinical development at a global pharmaceutical company. He holds an MD, a PhD in anatomy and cell biology, a graduate diploma in applied biostatistics, and four patents, and has published 49 journal articles. He is the founder of Selim Medical Press and the author of Signal Management in Pharmacovigilance and the Medical Device Safety Series.
