Böcker av Shalinee Naidoo

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.

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 devices 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.

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 manufacturers 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.

New and emerging technologies as well as various well-known incidents within the medical device industry have challenged the current framework, highlighted gaps and pointed to a certain scarcity of skills and expertise. For this reason, there was increasing need to update the European Medical Device Directives. This has since led to the development and release of the Medical Device Regulation (MDR 2017/745) which has now put stricter regulatory controls on the entire product life cycle. Both the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) contain a complete section on economic operators for medical devices. Although the manufacturer is ultimately responsible for ensuring their medical device is compliant with the relevant legislation, the various defined economic operators within the Regulation, now have a part to play in ensuring the safety and performance of the device throughout the supply chain. This new policy of sharing compliance is an important component of the MDR2017/745 with each economic operator serving as a control on the other, causing each device to receive a number of checks throughout the process before it is brought to market. In addition to this, it also allows for any compliance issues emerging from any one of the economic operators to have a direct legal implication on the other. Changes brought about by the MDR2017/745 in Europe require not only manufacturers but all defined economic operators to take a proactive, multilevel and multidisciplinary approach when it comes to ensuring safe and effective devices are placed on the market. This volume looks at each Economic Operator in greater details with their relevant responsibilities.

Provides 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).

Presents the concepts of biocompatible medical devices. 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.

Provides an overview of how regulatory systems work and what goes into implementing a simple regulatory framework. The book also highlights the importance of long-lasting good governance where regulation of medical devices is concerned and provides a step-by-step approach on the development of national regulatory programs.

Looks at medical devices and the effects that the global trends have on their usage and demand. The book explores research aimed at improving medical devices and the various solutions to overcome the barriers in the choosing of medical devices.

The seven-volume Encyclopedia of Environmental Science includes comprehensive information related to environmental science which features cutting-edge information that highlight recent and ongoing developments and research within environmental science.

Dealing with the principles of economics to the study of how environmental and natural resources are developed and managed; this volume is packed with novel approaches to the formulation of environmental policy by establishing the links between the environment and the economy, such as renewable energy, construction of hydroelectric power plants or transnational pipelines, and pollution control measures.

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, the role of women, environmental protection, sustainability and food security aspects in achieving sustainable water management.

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. Presenting a rationale for 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.

Wetlands are ecologically as well as economically important systems due to their high productivity, their nutrient (re)cycling capacities, and their prominent contribution to global greenhouse gas emissions. This volume contributes to the widespread information on the microbiology of wetlands and discusses the gaps therein to be assessed in future wetland research.

Ecological diversity is the intricate network of different species present in different ecosystems and the dynamic interaction between them. This timely volume examines the impact of the loss of biodiversity and ecotheology. It brings together the latest information on the rapid advances and developments in the field of biological diversity, habitats and climate.

Offers important insights and a unique perspective on ecosystems, and aims to maintain healthy and resilient forest ecosystems by focusing on a reduction of differences between natural and managed landscapes to ensure long-term maintenance of ecosystem functions and thereby retaining biodiversity.

Highlights new and emerging uses of stable isotope analysis in a variety of ecological disciplines. This volume presents a variety of scientific ecological issues and uses these to examine a range of environmental problems while considering potential engineering, scientific, and managerial solutions.

Provides an introduction into the history and principles of centrifugation as well as an in depth explanation of the history and principles surrounding centrifugation. The book also provides an explanation of commonly used centrifugation techniques and their related practical applications in various industries.