Handbook of Medical Device Regulatory Affairs in Asia
Handbook of Medical Device Regulatory Affairs in Asia

Author: Jack Wong

Publisher: CRC Press

Published: 2013-03-27

Total Pages: 618

ISBN-13: 9814411213

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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.

The Combination Products Handbook
The Combination Products Handbook

Author: Susan Neadle

Publisher: CRC Press

Published: 2023-05-16

Total Pages: 439

ISBN-13: 1000874583

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Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.

Risk Assessment in the Federal Government
Risk Assessment in the Federal Government

Author: National Research Council

Publisher: National Academies Press

Published: 1983-02-01

Total Pages: 206

ISBN-13: 0309033497

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The regulation of potentially hazardous substances has become a controversial issue. This volume evaluates past efforts to develop and use risk assessment guidelines, reviews the experience of regulatory agencies with different administrative arrangements for risk assessment, and evaluates various proposals to modify procedures. The book's conclusions and recommendations can be applied across the entire field of environmental health.

Medical Regulatory Affairs
Medical Regulatory Affairs

Author: Jack Wong

Publisher: CRC Press

Published: 2022-01-27

Total Pages: 806

ISBN-13: 1000440516

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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.

Medical Device Cybersecurity for Engineers and Manufacturers
Medical Device Cybersecurity for Engineers and Manufacturers

Author: Axel Wirth

Publisher: Artech House

Published: 2020-08-31

Total Pages: 270

ISBN-13: 163081816X

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Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussion… Nevertheless, we must proceed with urgency. In the end, this is about preventing patient harm and preserving patient trust. A comprehensive guide to medical device secure lifecycle management, this is a book for engineers, managers, and regulatory specialists. Readers gain insight into the security aspects of every phase of the product lifecycle, including concept, design, implementation, supply chain, manufacturing, postmarket surveillance, maintenance, updates, and end of life. Learn how to mitigate or completely avoid common cybersecurity vulnerabilities introduced during development and production. Grow your awareness of cybersecurity development topics ranging from high-level concepts to practical solutions and tools. Get insight into emerging regulatory and customer expectations. Uncover how to minimize schedule impacts and accelerate time-to-market while still accomplishing the main goal: reducing patient and business exposure to cybersecurity risks. Medical Device Cybersecurity for Engineers and Manufacturers is designed to help all stakeholders lead the charge to a better medical device security posture and improve the resilience of our medical device ecosystem.

Plastics in Medical Devices
Plastics in Medical Devices

Author: Vinny R. Sastri

Publisher: Elsevier

Published: 2010-03-05

Total Pages: 289

ISBN-13: 081552028X

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No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.

Advances in Informatics, Management and Technology in Healthcare
Advances in Informatics, Management and Technology in Healthcare

Author: J. Mantas

Publisher: IOS Press

Published: 2022-08-05

Total Pages: 616

ISBN-13: 1643682911

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Data science, informatics and technology have inspired health professionals and informaticians to improve healthcare for the benefit of all patients, and the field of biomedical and health informatics is one which has become increasingly important in recent years. This volume presents the papers delivered at ICIMTH 2022, the 20th International Conference on Informatics, Management, and Technology in Healthcare, held in Athens, Greece, from 1-3 July 2022. The ICIMTH Conference is an annual scientific event attended by scientists from around the world working in the field of biomedical and health informatics. This year, thanks to the improvement in the situation as regards the COVID-19 pandemic and the consequent lifting of restrictions, the conference was once again a live event, but virtual sessions by means of teleconferencing were also enabled for those unable to travel due to local restrictions. The field of biomedical and health informatics was examined from a very broad perspective, with participants presenting the research and application outcomes of informatics from cell to populations, including several technologies such as imaging, sensors, biomedical equipment, and management and organizational aspects, including legal and social issues. More than 230 submissions were received, with a total of 130 accepted as full papers and 19 as short communication and poster papers after review. As expected, a significant number of papers were related to the COVID-19 pandemic. Providing a state-of-the-art overview of biomedical and health informatics, the book will be of interest to all those working in the field of healthcare, researchers and practitioners alike

Why Quality is Important and How It Applies in Diverse Business and Social Environments, Volume I
Why Quality is Important and How It Applies in Diverse Business and Social Environments, Volume I

Author: Paul Hayes

Publisher: Business Expert Press

Published: 2020-12-24

Total Pages: 202

ISBN-13: 1947098543

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These two volumes are about understanding—why—and application—how—with the aim of providing guidance and introduction to both. Quality is the consistent achievement of the user’s expectations of a product or service. The achievement needs to be “The right thing, right first time, every time, in time.” Beginning with manufacturing and services, it also includes professional, personal, and spiritual dimensions. Variation does not sit happily with consistency and skill in handling risk and opportunity requires competence in the use of statistics, probability, and uncertainty; and needs to complement the critically essential soft dimensions of quality and the overarching and underpinning primacy of personal relationships. There are no clear boundaries to the applicability of quality and the related processes and procedures expressed in management systems, and this is why it matters so much to show “how it applies in diverse business and social environments.” Increasingly, the acceptability of boundaries that are drawn depends on their effect on the user and the achievement of quality, and the latest standards on quality management are explicit on this key point. Quality is everyone’s business, and there is no single professional discipline that can properly express this. Insights, knowledge, experience, best practice, tools, and techniques need to be shared across all kinds of organizational and professional boundaries, and there is no departmental boundary that can stand apart from the organization-wide commitment to quality achievement.

Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations
Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations

Author: Philip S. Cosgriff

Publisher: CRC Press

Published: 2024-03-26

Total Pages: 223

ISBN-13: 1040002358

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This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house. It compares requirements and latest regulations in different global territories, including the most recent EU regulations as well as UK and US regulations. This book is a valuable resource for practising clinical scientists producing medical software in-house, in addition to other medical staff writing small apps for clinical use, clinical scientist trainees, and software engineers considering a move into healthcare. The academic level is post-graduate, as readers will require a basic knowledge of software engineering principles and practice. Key Features: Up to date with the latest regulations in the UK, the EU, and the US Useful for those producing medical software for routine clinical use Contains best practice

Handbook of Pharmaceutical Manufacturing Formulations, Third Edition
Handbook of Pharmaceutical Manufacturing Formulations, Third Edition

Author: Sarfaraz K. Niazi

Publisher: CRC Press

Published: 2019-12-06

Total Pages: 614

ISBN-13: 1351593323

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The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Four, Semisolid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this fourth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features:  Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions  Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing  Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements  Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines