Articoli correlati a Applied Medical Device Safety: A Comprehensive Guide
Applied Medical Device Safety: A Comprehensive Guide - Brossura
Libro 5 di 5: Medical Device Safety Series
Sinossi
A medical device passes through many hands — designed by engineers, cleared by regulators, chosen by physicians, and used minute by minute by nurses — and its safety lives in the seams between those roles. Applied Medical Device Safety: A Comprehensive Guide is the rare book written for all of them at once, tracing a device's full life from design to disposal while teaching the working discipline that keeps patients safe at every stage.
Part narrative and part training manual, the book builds from first principles: what a device is and how it is classified, the regulatory landscape it lives within, and the ISO 14971 risk-management process carried out end to end. From there it moves through the safety work of development — quality systems (ISO 13485), biocompatibility (ISO 10993), materials, and clinical evaluation — and into the market, where safety becomes a matter of maintenance, training, vigilance, and the structured investigations that follow an adverse event.
At its operational heart is the Safety Specialist's Task Manual: step-by-step procedures for the tasks the role actually performs — writing and processing a case safety report, assessing causality, preparing aggregate reports and the PSUR, running a risk assessment, and constructing a defensible benefit–risk analysis — each with a working template, a fully solved example, and a self-check. Real device failures are then examined directly, and ready-to-adapt templates and interactive tools turn the methods into working aids.
Whether you are a nurse or physician moving into device safety, an engineer who must defend a design in the regulatory file, or a professional who wants to become a medical device safety specialist, this is a single volume that explains the field and shows you how to do its work.
Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.
Risultati della ricerca per Applied Medical Device Safety: A Comprehensive Guide
Foto dell'editore
Applied Medical Device Safety (Paperback)
Print on DemandDa: Grand Eagle Retail, Bensenville, IL, U.S.A.
Valutazione del venditore 5 su 5 stelle
Paperback. Condizione: new. Paperback. A medical device passes through many hands - designed by engineers, cleared by regulators, chosen by physicians, and used minute by minute by nurses - and its safety lives in the seams between those roles. Applied Medical Device Safety: A Comprehensive Guide is the rare book written for all of them at once, tracing a device's full life from design to disposal while teaching the working discipline that keeps patients safe at every stage.Part narrative and part training manual, the book builds from first principles: what a device is and how it is classified, the regulatory landscape it lives within, and the ISO 14971 risk-management process carried out end to end. From there it moves through the safety work of development - quality systems (ISO 13485), biocompatibility (ISO 10993), materials, and clinical evaluation - and into the market, where safety becomes a matter of maintenance, training, vigilance, and the structured investigations that follow an adverse event.At its operational heart is the Safety Specialist's Task Manual: step-by-step procedures for the tasks the role actually performs - writing and processing a case safety report, assessing causality, preparing aggregate reports and the PSUR, running a risk assessment, and constructing a defensible benefit-risk analysis - each with a working template, a fully solved example, and a self-check. Real device failures are then examined directly, and ready-to-adapt templates and interactive tools turn the methods into working aids.Whether you are a nurse or physician moving into device safety, an engineer who must defend a design in the regulatory file, or a professional who wants to become a medical device safety specialist, this is a single volume that explains the field and shows you how to do its work. This item is printed on demand. Shipping may be from multiple locations in the US or from the UK, depending on stock availability. Codice articolo 9798176445893
Compra nuovo
EUR 63,77
Spedizione gratuita
Spedito in U.S.A.
Spedito in U.S.A.
Quantità: 1 disponibili
Foto dell'editore
Applied Medical Device Safety
Print on DemandDa: PBShop.store US, Wood Dale, IL, U.S.A.
Valutazione del venditore 5 su 5 stelle
PAP. Condizione: New. New Book. Shipped from UK. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000. Codice articolo L0-9798176445893
Compra nuovo
EUR 63,78
Spedizione gratuita
Spedito in U.S.A.
Spedito in U.S.A.
Quantità: Più di 20 disponibili
Foto dell'editore
Applied Medical Device Safety
Print on DemandDa: PBShop.store UK, Fairford, GLOS, Regno Unito
Valutazione del venditore 5 su 5 stelle
PAP. Condizione: New. New Book. Delivered from our UK warehouse in 4 to 14 business days. THIS BOOK IS PRINTED ON DEMAND. Established seller since 2000. Codice articolo L0-9798176445893
Compra nuovo
EUR 61,39
Spedizione EUR 3,93
Spedito da Regno Unito a U.S.A.
Spedito da Regno Unito a U.S.A.
Quantità: Più di 20 disponibili
Foto dell'editore
Applied Medical Device Safety: A Comprehensive Guide (Medical Device Safety Series)
Print on DemandDa: California Books, Miami, FL, U.S.A.
Valutazione del venditore 5 su 5 stelle
Condizione: New. Print on Demand. Codice articolo I-9798176445893
Compra nuovo
EUR 67,40
Spedizione EUR 2,69
Spedito in U.S.A.
Spedito in U.S.A.
Quantità: Più di 20 disponibili
Foto dell'editore
Applied Medical Device Safety (Paperback)
Print on DemandDa: CitiRetail, Stevenage, Regno Unito
Valutazione del venditore 5 su 5 stelle
Paperback. Condizione: new. Paperback. A medical device passes through many hands - designed by engineers, cleared by regulators, chosen by physicians, and used minute by minute by nurses - and its safety lives in the seams between those roles. Applied Medical Device Safety: A Comprehensive Guide is the rare book written for all of them at once, tracing a device's full life from design to disposal while teaching the working discipline that keeps patients safe at every stage.Part narrative and part training manual, the book builds from first principles: what a device is and how it is classified, the regulatory landscape it lives within, and the ISO 14971 risk-management process carried out end to end. From there it moves through the safety work of development - quality systems (ISO 13485), biocompatibility (ISO 10993), materials, and clinical evaluation - and into the market, where safety becomes a matter of maintenance, training, vigilance, and the structured investigations that follow an adverse event.At its operational heart is the Safety Specialist's Task Manual: step-by-step procedures for the tasks the role actually performs - writing and processing a case safety report, assessing causality, preparing aggregate reports and the PSUR, running a risk assessment, and constructing a defensible benefit-risk analysis - each with a working template, a fully solved example, and a self-check. Real device failures are then examined directly, and ready-to-adapt templates and interactive tools turn the methods into working aids.Whether you are a nurse or physician moving into device safety, an engineer who must defend a design in the regulatory file, or a professional who wants to become a medical device safety specialist, this is a single volume that explains the field and shows you how to do its work. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability. Codice articolo 9798176445893
Compra nuovo
EUR 75,05
Spedizione EUR 44,20
Spedito da Regno Unito a U.S.A.
Spedito da Regno Unito a U.S.A.
Quantità: 1 disponibili
Foto dell'editore
Applied Medical Device Safety : A Comprehensive Guide
Da: AHA-BUCH GmbH, Einbeck, Germania
Valutazione del venditore 5 su 5 stelle
Taschenbuch. Condizione: Neu. Neuware - A medical device passes through many hands - designed by engineers, cleared by regulators, chosen by physicians, and used minute by minute by nurses - and its safety lives in the seams between those roles. Applied Medical Device Safety: A Comprehensive Guide is the rare book written for all of them at once, tracing a device's full life from design to disposal while teaching the working discipline that keeps patients safe at every stage.Part narrative and part training manual, the book builds from first principles: what a device is and how it is classified, the regulatory landscape it lives within, and the ISO 14971 risk-management process carried out end to end. From there it moves through the safety work of development - quality systems (ISO 13485), biocompatibility (ISO 10993), materials, and clinical evaluation - and into the market, where safety becomes a matter of maintenance, training, vigilance, and the structured investigations that follow an adverse event.At its operational heart is the Safety Specialist's Task Manual: step-by-step procedures for the tasks the role actually performs - writing and processing a case safety report, assessing causality, preparing aggregate reports and the PSUR, running a risk assessment, and constructing a defensible benefit-risk analysis - each with a working template, a fully solved example, and a self-check. Real device failures are then examined directly, and ready-to-adapt templates and interactive tools turn the methods into working aids.Whether you are a nurse or physician moving into device safety, an engineer who must defend a design in the regulatory file, or a professional who wants to become a medical device safety specialist, this is a single volume that explains the field and shows you how to do its work. Codice articolo 9798176445893
Compra nuovo
EUR 92,77
Spedizione EUR 35,00
Spedito da Germania a U.S.A.
Spedito da Germania a U.S.A.
Quantità: 2 disponibili