Legal Texts on Medical Devices and Equipment :. PDF Download
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Author:
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Category :
Languages : en
Pages : 0
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Book Description
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
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Book Description
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 0
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Book Description
Author: I. Glenn Cohen
Publisher: Cambridge University Press
ISBN: 1108838634
Category : Law
Languages : en
Pages : 295
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Book Description
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Author: Jonathan S. Kahan
Publisher:
ISBN: 9780996346276
Category : Medical instruments and apparatus
Languages : en
Pages : 658
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Book Description
Author: Almir Badnjević
Publisher: Springer
ISBN: 9811066507
Category : Technology & Engineering
Languages : en
Pages : 285
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Book Description
This book offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations. It describes the processes, procedures and need for integrating medical devices into the legal metrology framework, addresses their independent safety and performance verification, and highlights the associated savings for national healthcare systems, all with the ultimate goal of increasing the efficacy and reliability of patient diagnoses and treatment. The book primarily focuses on diagnostic and therapeutic medical devices, and reflects the latest international directives and regulations. Above all, the book demonstrates that integrating medical devices into the legal metrology system and establishing a fully operational national laboratory for the inspection of medical devices could significantly improve the reliability of medical devices in diagnosis and patient care, while also reducing costs for the healthcare system in the respective country.
Author: Emily Jackson
Publisher: Oxford University Press
ISBN: 0198743505
Category : Law
Languages : en
Pages : 1065
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Book Description
Providing a clear and accessible guide to medical law, this work contains extracts from a wide variety of academic materials so that students can acquire a good understanding of a range of different perspectives.
Author: Jonathan S. Kahan
Publisher:
ISBN: 9780988314436
Category : Medical instruments and apparatus
Languages : en
Pages : 622
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Book Description
Author: Charles Sidebottom
Publisher: CRC Press
ISBN: 9780367395162
Category :
Languages : en
Pages : 616
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Book Description
Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide and provides examples of compliance and noncompliance. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, over the counter products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more.
Author: James Beck
Publisher: Law Journal Press
ISBN: 9781588521217
Category : Actions and defenses
Languages : en
Pages : 982
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Book Description
This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Author: Beth Ann Fiedler
Publisher: Elsevier
ISBN: 0128041927
Category : Law
Languages : en
Pages : 382
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Book Description
Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices Provides operational and clinical practice recommendations in regard to regulatory changes for risk management Discusses best practices for equipment procurement and maintenance Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices
