Regulatory Affairs For Biomaterials And Medical Devices

Author : Stephen F. Amato,Robert M. Ezzell Jr
Publisher : Elsevier
Page : 202 pages
File Size : 55,6 Mb
Release : 2014-10-27
Category : Medical
ISBN : 9780857099204

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Regulatory Affairs for Biomaterials and Medical Devices by Stephen F. Amato,Robert M. Ezzell Jr Pdf

All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing

Author : Jack Wong,Raymond K. Y. Tong
Publisher : CRC Press
Page : 620 pages
File Size : 54,6 Mb
Release : 2022-01-27
Category : Medical
ISBN : 9781000440539

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Medical Regulatory Affairs by Jack Wong,Raymond K. Y. Tong Pdf

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

Author : John J. Tobin,Gary Walsh
Publisher : John Wiley & Sons
Page : 304 pages
File Size : 46,6 Mb
Release : 2011-08-24
Category : Science
ISBN : 9783527644711

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Medical Product Regulatory Affairs by John J. Tobin,Gary Walsh Pdf

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Author : Jack Wong,Raymond Tong Kaiyu
Publisher : CRC Press
Page : 618 pages
File Size : 45,9 Mb
Release : 2013-03-27
Category : Medical
ISBN : 9789814411219

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Handbook of Medical Device Regulatory Affairs in Asia by Jack Wong,Raymond Tong Kaiyu Pdf

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.

Author : Jack Wong,Raymond Tong
Publisher : CRC Press
Page : 494 pages
File Size : 47,8 Mb
Release : 2018-03-28
Category : Medical
ISBN : 9780429996764

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Handbook of Medical Device Regulatory Affairs in Asia by Jack Wong,Raymond Tong Pdf

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.

Author : Dr. John J. Tobin,Gary Walsh (Biochemist)
Publisher : Unknown
Page : 0 pages
File Size : 46,6 Mb
Release : 2024
Category : Drugs
ISBN : 3527688994

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Medical Product Regulatory Affairs by Dr. John J. Tobin,Gary Walsh (Biochemist) Pdf

Author : Smita Gopalaswamy,Venky Gopalaswamy
Publisher : CRC Press
Page : 168 pages
File Size : 41,6 Mb
Release : 2008-04-22
Category : Business & Economics
ISBN : 9781040068960

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Combination Products by Smita Gopalaswamy,Venky Gopalaswamy Pdf

The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing

Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 45,6 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9789241546188

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Medical Device Regulations by Michael Cheng,World Health Organization Pdf

The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publisher : Woodhead Publishing
Page : 256 pages
File Size : 46,7 Mb
Release : 2015-08-18
Category : Medical
ISBN : 9780081002919

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Medical Devices by Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo Pdf

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process

Author : G.R Higson
Publisher : CRC Press
Page : 278 pages
File Size : 50,8 Mb
Release : 2001-10-29
Category : Medical
ISBN : 9781420033984

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Medical Device Safety by G.R Higson Pdf

Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en

Author : Val Theisz
Publisher : CRC Press
Page : 590 pages
File Size : 46,8 Mb
Release : 2015-08-03
Category : Medical
ISBN : 9789814669115

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Medical Device Regulatory Practices by Val Theisz Pdf

This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

Author : Gloria Hall,Pamela Anne Jones
Publisher : Unknown
Page : 726 pages
File Size : 43,5 Mb
Release : 2020-07-29
Category : Medical instruments and apparatus
ISBN : 1947493493

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Fundamentals of Medical Device Regulations, Third Edition by Gloria Hall,Pamela Anne Jones Pdf

Fundamentals of Medical Device Regulations is a compilation of history, medical device and in vitro diagnotic (IVD) medical device information from RAPS' regional publications: Fundamentals of US Regulatory Affairs, Eleventh Edition; Fundamentals of Canadian Medical Device Regulations; Fundamentals of EU Regulatory Affairs, Ninth Edition; Fundamentals of International Regulatory Affairs, Fourth Edition."--Foreword.

Author : Shayne Cox Gad,Samantha Gad-McDonald
Publisher : CRC Press
Page : 606 pages
File Size : 50,8 Mb
Release : 2015-12-01
Category : Medical
ISBN : 9781482248388

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Biomaterials, Medical Devices, and Combination Products by Shayne Cox Gad,Samantha Gad-McDonald Pdf

Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for-or concerned with-developing and ensuring patient safety in the use and manufacture of medical devices.The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical

Author : Marie B. Teixeira,Richard Bradley
Publisher : CRC Press
Page : 253 pages
File Size : 51,8 Mb
Release : 2002-09-20
Category : Medical
ISBN : 9780824743550

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Design Controls for the Medical Device Industry by Marie B. Teixeira,Richard Bradley Pdf

This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA audit identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies determine the compatibility of design specifications and manufacturing, installation, and servicing demands ensure that proper design, function, and performance stipulations are understood and met verify and validate design criteria and production schemes eliminate confusion and prevent communication breakdowns allocate and conserve resources perform risk assessment analyses predict potential hazards under normal and fault conditions Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.

Author : Marie B. Teixeira
Publisher : CRC Press
Page : 208 pages
File Size : 54,9 Mb
Release : 2013-11-12
Category : Medical
ISBN : 9781466503540

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Design Controls for the Medical Device Industry, Second Edition by Marie B. Teixeira Pdf

The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.