Brookwood Medical Publications

Regulatory

Dictionary of regulatory terminology for medical devices
This dictionary is a tool to aid professionals in the regulatory, clinical, quality, engineering and research areas. It is designed for manufacturers and top management alike to understand the terms being used in the medical device industry today. Various terms can mean different things under various regulatory systems and so this attempts to gather all the relevant terminology and abbreviations commonly used in these areas into a single reference guide.

ISBN 1-874409-88-9

FAQs on EU Pharmaceutical Regulatory Affairs
This report guides the reader through the minefield of European bureaucracy by setting out the who, what, when, where and how of conducting clinical trials in the European Union, in an easily accessible FAQs format.

Issues range from a general introduction to questions that arise when considering confidentiality, bio-ethics, fraud, data management and adverse event reporting.

ISBN 1-874409-17-X

FAQs on EU Medical Device Regulatory Affairs
Part II - Understanding the Main Issues of European Compliance
This FAQ is the second in a two part series focusing on understanding and implementing the Medical Device Directive 93/42/EEC. This booklet delves into the practicalities of compliance itself and is interspersed with tips, hints and recommendations. Compliance with the European Union Directives can be confusing for many companies and their representatives whether they are located in the European Union or not. This report examines the definition of terms, simplifies and explains each of the elements required for compliance to the directive. It is an invaluable resource for all professionals working in the medical device field.

ISBN 1-874409-83-8

European Union Guidelines relating to Human Medicinal Products
This report is essential for professionals involved in the development and registration of medicinal products. It contains over 350 guidelines for obtaining marketing authorisation for human-use medicines.

ISBN 1-874409-63-3

A Guide to Marketing Authorisation Procedures in the EU
This report is an introduction and guide to the way in which human medicinal products are authorised for marketing in the European Union.

ISBN 1-874409-48-x

FAQs on EU Medical Device Regulatory Affairs
Part I � Understanding the Directives and the Role of Key Participants
This booklet is the first in a 2 part series focusing on understanding and implementing the Medical Device Directive 93/42/EEC.

ISBN 1-874409-78-1

Planning The Design Control Process
This book focuses on the design control process for medical devices, which ensures the safety and efficacy of medical devices introduced on the market.

ISBN 1-874409-13-7

Practical Guide to Medical Device Vigilance
This book is a guide to the reporting of adverse events occurring in the use of medical devices and to an understanding of the EU Medical Device Vigilance (MEDEV,2.12/1) guidelines.

ISBN 1-874409-08-0

	Dictionary of regulatory terminology for medical devices This dictionary is a tool to aid professionals in the regulatory, clinical, quality, engineering and research areas. It is designed for manufacturers and top management alike to understand the terms being used in the medical device industry today. Various terms can mean different things under various regulatory systems and so this attempts to gather all the relevant terminology and abbreviations commonly used in these areas into a single reference guide. ISBN 1-874409-88-9

	FAQs on EU Pharmaceutical Regulatory Affairs This report guides the reader through the minefield of European bureaucracy by setting out the who, what, when, where and how of conducting clinical trials in the European Union, in an easily accessible FAQs format. Issues range from a general introduction to questions that arise when considering confidentiality, bio-ethics, fraud, data management and adverse event reporting. ISBN 1-874409-17-X

	FAQs on EU Medical Device Regulatory Affairs Part II - Understanding the Main Issues of European Compliance This FAQ is the second in a two part series focusing on understanding and implementing the Medical Device Directive 93/42/EEC. This booklet delves into the practicalities of compliance itself and is interspersed with tips, hints and recommendations. Compliance with the European Union Directives can be confusing for many companies and their representatives whether they are located in the European Union or not. This report examines the definition of terms, simplifies and explains each of the elements required for compliance to the directive. It is an invaluable resource for all professionals working in the medical device field. ISBN 1-874409-83-8

	European Union Guidelines relating to Human Medicinal Products This report is essential for professionals involved in the development and registration of medicinal products. It contains over 350 guidelines for obtaining marketing authorisation for human-use medicines. ISBN 1-874409-63-3

	A Guide to Marketing Authorisation Procedures in the EU This report is an introduction and guide to the way in which human medicinal products are authorised for marketing in the European Union. ISBN 1-874409-48-x

	FAQs on EU Medical Device Regulatory Affairs Part I � Understanding the Directives and the Role of Key Participants This booklet is the first in a 2 part series focusing on understanding and implementing the Medical Device Directive 93/42/EEC. ISBN 1-874409-78-1

	Planning The Design Control Process This book focuses on the design control process for medical devices, which ensures the safety and efficacy of medical devices introduced on the market. ISBN 1-874409-13-7

	Practical Guide to Medical Device Vigilance This book is a guide to the reporting of adverse events occurring in the use of medical devices and to an understanding of the EU Medical Device Vigilance (MEDEV,2.12/1) guidelines. ISBN 1-874409-08-0