Manufacturers Must Understand the Implications of the 2014 Update to ISO 11135 on the Sterilisation of Medical Devices Using Ethylene Oxide
Summary
QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces.QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services.Therefore, I hope that this work can assist the reader in the daily application of the new standard and also prompt some fundamental questions that the standard does not seem to answer, so could be considered in the future,” says H Atchia.The English language article of 38 pages is available at www.qualityfirstint.com.RRP: £80 (plus VAT, as applicable).About Quality First International (QFI)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, Mexican and Chinese marketplaces.QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services.