How to classify your medical device under European Regulations

Author:   Shalinee Naidoo
Publisher:   Arcler Press
ISBN:  

9781774691878


Pages:   261
Publication Date:   30 December 2021
Format:   Hardback
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

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How to classify your medical device under European Regulations


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Overview

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.

Full Product Details

Author:   Shalinee Naidoo
Publisher:   Arcler Press
Imprint:   Arcler Press
Weight:   0.626kg
ISBN:  

9781774691878


ISBN 10:   1774691876
Pages:   261
Publication Date:   30 December 2021
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

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Shalinee Naidoo is currently the Regulatory and Product Development Manager of a medical device manufacturer based in South Africa. She is directly involved in global regulatory compliance and the design and development of new medical devices from idea conception to market. She is also the founder of Life of Shal (www.lifeofshal.com) an online travel journal created to inspire others to explore the world and Scientist's Sanctuary (www.scientistssanctuary.com) - a science communication company that specializes in bridging the gap between scientific knowledge and creative communication for both the academic and corporate world.

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