The Long Life of a Safe Device: Medical Device Safety from Design to Disposal - Couverture souple

SELIM MD PhD, Dr. HAFEZ

Couverture souple

ISBN 13 : 9798187048007

Editeur : Independently published, 2026

Synopsis

Safety is never one person's job.
A medical device is designed by engineers, cleared by regulators, chosen by physicians, and used — minute by minute — by nurses. Each holds a piece of its safety that no one else can hold for them. Yet almost every book on the subject speaks to only one of these readers. The Long Life of a Safe Device is written for all of them at once.
This is a practical, plain-spoken guide to keeping medical devices — and the patients who depend on them — safe across a device's entire lifecycle, from the first design decision to final disposal. It turns the core disciplines of device safety into a single, readable narrative, and wherever a point lands differently for a nurse, a physician, or an engineer, a short labeled aside says so.
Inside this book:

What a medical device is, how it's classified, and the global regulatory landscape (FDA, EU MDR/IVDR, and beyond)
Risk management the way ISO 14971 intends it — from hazard identification and estimation to risk controls and residual risk
Safety built in during development: quality systems (ISO 13485), biocompatibility (ISO 10993), materials of animal origin, and clinical evaluation
Safety defended in the market: maintenance, user training, vigilance and incident response, causality assessment, post-market surveillance, PMCF, and PSURs
Real device failures — an insulin pump, a pacemaker, an MRI scanner, a defibrillator — and the specific discipline that would have caught each one

Who it's for:
Nurses and clinicians at the point of care. Physicians selecting and overseeing devices. Design, quality, and regulatory engineers who build the evidence. Safety and pharmacovigilance professionals who monitor devices in use. Students and newcomers who want the whole picture in one place.
Clear enough to read cover to cover and organized to return to as a reference, The Long Life of a Safe Device gives every member of the team not only their own responsibility — but the visibility to trust their colleagues are holding theirs.
Written by Hafez Selim, MD, PhD, a physician and scientist with deep experience in medical device and drug safety across the product lifecycle, from premarket development through post-market surveillance.

Détails de l'édition

• Éditeur: Independently published
• Date d'édition: 2026
• Langue: anglais
• ISBN 13: 9798187048007
• Reliure: Paperback
• Nombre de pages: 85
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible