Introduction to the fundamentals of classification: Haroon Atchia from QFI writes new guidance document published by Global Regulatory Press
London, 21 October 2009
Haroon Atchia from Quality First International has written a new guidance document entitled “Principles and Practice of Medical Device Classification”.
The guidance document, published by Global Regulatory Press, presents an introduction to the principles and practice of classification of medical devices. It expands education on the classification system described by the European Medical Devices Directive, introducing the reader to the fundamentals of classification, in an attempt to explore the origin, design, construction and practice of the scheme according to the theory and practice of classification.
According to the guidance document’s author, Mr Haroon Atchia, “The prospect of writing any kind of text to examine the principles of classification and application to regulation of medical devices was conceived originally to offer the analytically-literate regulatory assurance professional an introduction to the reasons for classification of such products around the world. As the report developed, it transpired that the most widely used classification schemes fail to adhere to the fundamental principles of the discipline; in fact, they suffer from some basic flaws. It is hoped, therefore, that this guidance document conveys the importance of analysis and thorough, scientific re-appraisal of some of the prevailing schemes or, if not this, then that it serves as a useful reference for design of future classification schemes for medical devices”.
This guidance document is suitable for manufacturing personnel needing an introduction to European product classification, specialists performing or assessing classification, and regulatory specialists in manufacturers and regulatory authorities.
A large, detailed flowchart depicting the product classification process according to Annex IX to Council Directive 93/42/EEC (as amended) is also included.
Specification: 121 pages plus covers, plus accompanying flowchart, in English, supplied by email as a PDF. Price: £175 (plus VAT, where applicable). ISBN-13: 978-1-903757-05-5. Purchases via www.globalregulatorypress.com.
About Quality First International (QFI)
Quality First International (QFI) is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting-edge, minimally invasive and cardiovascular products and implants.
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