Shalinee Naidoo - Böcker

Water is a key driver of economic and social development while it also has a basic function in maintaining the integrity of the natural environment. Presents the rationale approach for the Integrated Water Resources Management; this volume brings together both the different environmental problems that affect the very different ecosystems and the main methodologies able to face the problem of IWM. It will be of an invaluable resource for those involved in urban water management, including water utility managers, engineering technical staff, operations and maintenance specialists.

Water resources and services are integrated measures of social systems that range beyond the technical world and the IWRM requires a balance between competing views of social and political issues. This volume focuses on increased awareness of the human dimension, women’s role, environmental protection, sustainability and food security aspects in achieving sustainable water management. Understanding the strategies used by small farmers, as well as how small farming systems work or why they fail, could shed light on the constraints they face and the measures to be taken to overcome them. It also draws key insights on movements promoting the involvement of grassroots communities in the sustainable management of their resources.

Understanding Medical Devices: An Introduction to the Medical Device Industry throws light on the meaning of medical devices and the effects that the global trends have on their usage and demand. It informs about the research that is aimed at improving the medical devices and the various solutions to overcome the barriers in the choosing of medical devices. The book makes the readers understand the various guidelines for medical device donations and throws light on the importance of public health in this sector. Also discussed in the book are the examples of various medical devices, the essential principles of safety and performance, the use of standards by the regulatory bodies, the various phases of medical device development, the responsible entity for the medical devices and the way the medical device industry has globalized.

As innovation and rapid advancement in technologies take over, medical devices have now become one of the fastest-growing industries globally. In 2000, it was estimated that one and half million different medical devices were available on the market worldwide. For many countries, their regulatory systems have proven to be ineffective in quality management and in monitoring the domestic market to prevent unsafe and low-quality medical products from entering. The lack of harmonized processes when assessing the safety and efficacy or performance of medical products has also led to an increase in costs associated with licensing where required. Regulatory controls for medical devices are often complicated to implement due to the many different types of devices available on the market. Often the risks associated with each type of device differ, making the opportunity for misuse considerable. The purpose of this book is to provide readers with an overview of how regulatory systems work and what goes into implementing a simple regulatory framework. It also aims to highlight the importance of long-lasting good governance where regulation of medical devices is concerned and to provide a step-by-step approach on the development of national regulatory programs for medical devices. It looks at what are some of the guiding principles and essential features of a simple medical device regulatory program, what governs the safety of medical devices and who is responsible for implementation, applying conformity assessment rules and the use of standards to guide a regulatory model.

Biocompatibility, is by definition, a measurement of how compatible a device is with a biological system. The purpose of performing biocompatibility testing is to determine the safety of a device for human use, taking into consideration the intended use and specific legal requirements at the time of registration. This is essential to determine whether a device has the potential to cause adverse effects as many devices may be subject to degradation when implanted into tissues or subjected to the surrounding degradation effects of body. Manufacturers must be able to show safety of all device components and the finished device through acceptable toxicological data and related literature. If a manufacturer cannot show this information, then their device will need to undergo testing. This volume aims to provide a simple understanding around the concepts of biocompatible medical devices. Much information is provided to help manufacturers when choosing appropriate tests and to ensure that biomaterials and finished devices are safe and will perform as intended when used in a clinical setting. Key concepts of the ISO 10993 series of standards is provided as well as some of the major challenges faced by medical device manufacturers when considering biocompatibility testing. A simple understanding around the evaluation and characterization of biocompatible materials as well as the regulation of such devices are provided. In addition, a simplified overview of how to set up a basic biocompatibility testing laboratory is also included.

In recent times the need for improving regulatory controls and finding ways to improve the quality and access to safe medical devices has increased. The Medical Devices Directive 93/42/EEC was enforced to provide a harmonised regulatory environment for all medical devices sold within the European Union however new and emerging technologies as well as various well-known incidents within the medical device industry have challenged the current framework and highlighted gaps and a scarcity of skills and expertise. For this reason, there has been an increasing need to update the MDD which led to the development and release of the Medical Device Regulation (EU MDR 2017/745). This has since marked the start of a three-year transition period for manufacturers, suppliers, Notified Bodies, and National Competent Authorities. While compliance to the new regulation was set to take effect in May of 2020, it has now been postponed by a year due to the recent coronavirus pandemic. This has essentially given manufacturers more time to assess their overall readiness and reprioritize the time-consuming areas of the transition. This volume aims to provide an easy-to-understand guide for beginners to the medical device regulations in Europe and looks specifically at the changes between the current Medical Device Directive 93/42/EEC and forthcoming Medical Devices Regulation (EU MDR 2017/745) with regards to classification, conformity assessments and assessing general safety and performance requirements.

It is estimated that there are over 10 000 different medical devices available on the market today. These devices have become an integral part of health care and a vital component of the various activities carried out by health-care providers to treat people with varying medical conditions all around the world. Regulatory requirements for such devices differ from country to country all around the world which in turn make it difficult for manufacturers to obtain all round market approval for their products. While market approval from regulatory authorities can easily be obtained if a manufacturer can prove the device meets national regulatory guidelines; differences in regulatory requirements between different countries means that a manufacturer's registration process becomes more complex and ultimately may require additional resources or information. This volume aims to provide a basic roadmap to beginners into the medical device industry. It provides a simplistic overview of the vast history behind much of the regulations and medical technology governing the field today as well as the need and importance of associated medical device regulations and essential principles governing safe and effective manufacture and use of these devices.

The medical device sector is growing fast. Every day new technology which is both complex and smart are being added to the industry. Ensuring safe and effective use of medical devices for patients and users of the device itself is a crucial responsibility for manufacturers. When designing and manufacturing medical devices, safety, and efficacy should be of utmost importance. A manufacturer should never compromise on the clinical safety requirements of its users, patients or any other persons involved. Generally, the design of a medical device is regulated by the essential principles (EP) of safety and performance. What this means is that if a device is designed to relieve pain, the manufacturer must be able to clinically prove that the device can in fact relieve pain. Often this poses a great deal of challenges to manufacturers; however, building in appropriate safety and risk management functions across a device's lifecycle is imperative if they wish to reduce the risk of post-market problems. This volume aims to provide an overview of the harmonized essential principles that must be achieved in the design and development of medical devices. It provides an in-depth explanation of the relevant medical device regulations in Europe with a specific focus on the safety and performance requirements for medical devices.

Over the last 20 or so years, the number, range, and complexity of medical devices available on the market has increased drastically and as a result, so has the complexity of the regulations involved. With new and emerging technologies as well as various well-known incidents within the medical device industry, the current regulatory framework has since been challenged. In fact, many gaps and scarcity of skills and expertise have been identified. For this reason, there was an increasing need to update the current Medical Device Directive (MDD 93/42/EEC) in the European Union, which in turn led to the development and release of the Medical Device Regulation (EU MDR 2017/745). This volume aims to provide an easy-to-understand guide for beginners to the medical device regulations in Europe with specific focus on classification methods. It looks specifically at how to class a medical device based on the risk associated with it as well the details around the European Classification Systems provided in the MEDDEV 2.4/1. This volume also delves into the detail around defining borderline medical devices and how they are classified according to the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices as published by the European Commission.

Water Management in a Changing World is a comprehensive guide that delves into the crucial subject of water management in today's ever-evolving world. With an overview of the subject, this book aims to provide readers with a deep understanding of the challenges and complexities surrounding water resources. It explores innovative strategies for sustainable water use and conservation, addressing pressing issues such as climate change, population growth, and urbanization. Through engaging narratives, insightful analysis, and practical solutions, this book seeks to empower individuals, communities, and policymakers to make informed decisions and take proactive measures in managing water resources effectively. By fostering awareness and promoting responsible water management practices, this book ultimately strives to create a more sustainable and resilient future for generations to come.