ISO 14971
Author: International Organization for Standardization
Publisher:
Published: 2000
Total Pages: 32
ISBN-13: 9783860225547
DOWNLOAD EBOOKRead and Download eBook Full
Author: International Organization for Standardization
Publisher:
Published: 2000
Total Pages: 32
ISBN-13: 9783860225547
DOWNLOAD EBOOKAuthor: Bijan Elahi
Publisher: Academic Press
Published: 2021-11-11
Total Pages: 541
ISBN-13: 0323918239
DOWNLOAD EBOOKSafety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. Includes new coverage of ISO 14971:2019, ISO/TR 24971 Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation
Author: ISO.
Publisher:
Published: 2013
Total Pages: 0
ISBN-13:
DOWNLOAD EBOOKAuthor: NSAI. National Standards Authority of Ireland
Publisher:
Published: 2012
Total Pages: 0
ISBN-13:
DOWNLOAD EBOOKAuthor: Association for the Advancement of Medical Instrumentation
Publisher:
Published: 2020
Total Pages: 0
ISBN-13:
DOWNLOAD EBOOKAuthor: R. Timothy Stein
Publisher: Paton Professional
Published: 2006
Total Pages: 610
ISBN-13: 9781932828092
DOWNLOAD EBOOKAuthor: Jayet Moon
Publisher: Quality Press
Published: 2024-05-10
Total Pages: 195
ISBN-13: 1636941729
DOWNLOAD EBOOKWhen it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product’s life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).
Author: Gerardus Blokdyk
Publisher: 5starcooks
Published: 2018-05-08
Total Pages: 124
ISBN-13: 9780655190233
DOWNLOAD EBOOKAre there any specific expectations or concerns about the ISO 14971 team, ISO 14971 itself? How do mission and objectives affect the ISO 14971 processes of our organization? Who sets the ISO 14971 standards? How do we accomplish our long range ISO 14971 goals? What new services of functionality will be implemented next with ISO 14971 ? This amazing ISO 14971 self-assessment will make you the assured ISO 14971 domain veteran by revealing just what you need to know to be fluent and ready for any ISO 14971 challenge. How do I reduce the effort in the ISO 14971 work to be done to get problems solved? How can I ensure that plans of action include every ISO 14971 task and that every ISO 14971 outcome is in place? How will I save time investigating strategic and tactical options and ensuring ISO 14971 costs are low? How can I deliver tailored ISO 14971 advice instantly with structured going-forward plans? There's no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all ISO 14971 essentials are covered, from every angle: the ISO 14971 self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that ISO 14971 outcomes are achieved. Contains extensive criteria grounded in past and current successful projects and activities by experienced ISO 14971 practitioners. Their mastery, combined with the easy elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in ISO 14971 are maximized with professional results. Your purchase includes access details to the ISO 14971 self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows you exactly what to do next. Your exclusive instant access details can be found in your book.
Author: Gerardus Blokdyk
Publisher: 5starcooks
Published: 2019-09-05
Total Pages: 298
ISBN-13: 9780655912804
DOWNLOAD EBOOKWhat traceability activities are undertaken during the design phase? Is implementation of each risk control measure verified and recorded? Would clients and caregivers prefer to have access to the device? Who will use medical devices, and how will lives, abilities, and expectations change? When is a risk so low that there is no need to consider it? This easy ISO 14971 self-assessment will make you the dependable ISO 14971 domain specialist by revealing just what you need to know to be fluent and ready for any ISO 14971 challenge. How do I reduce the effort in the ISO 14971 work to be done to get problems solved? How can I ensure that plans of action include every ISO 14971 task and that every ISO 14971 outcome is in place? How will I save time investigating strategic and tactical options and ensuring ISO 14971 costs are low? How can I deliver tailored ISO 14971 advice instantly with structured going-forward plans? There's no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all ISO 14971 essentials are covered, from every angle: the ISO 14971 self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that ISO 14971 outcomes are achieved. Contains extensive criteria grounded in past and current successful projects and activities by experienced ISO 14971 practitioners. Their mastery, combined with the easy elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in ISO 14971 are maximized with professional results. Your purchase includes access details to the ISO 14971 self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows you exactly what to do next. Your exclusive instant access details can be found in your book. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation - In-depth and specific ISO 14971 Checklists - Project management checklists and templates to assist with implementation INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.