London, 25 January 2018 - The Editor of the Journal of Medical Device Regulation, Victoria Clark, announced today the appointment of Luciano Oliveira Ferreira, RAC to the Journal’s Editorial Advisory Board. The Journal, which reaches regulatory professionals around the world, welcomes yet another distinguished member of the international medical device regulatory community to its Advisory Board. “We are very pleased that Luciano has agreed to join our Editorial Advisory Board”, explains…

London, 14 January 2014 - With publication of the upcoming February 2014 edition, the Journal of Medical Device Regulation (www.globalregulatorypress.com) will have a new look. While the contents will remain the same – covering important changes and news in the international medical device regulatory arena – the updated presentation will emphasise the global nature of the quarterly publication. In particular, the News Section is being re-structured to reflect the categories of: Europe…

London, 15 May 2012 – The Editor of the Journal of Medical Device Regulation, Victoria Clark, announced today the appointment of Mario R Nacinovich to the Journal’s Editorial Advisory Board. Mario is Managing Partner for AXON, Editor-in-Chief of the Journal of Communication in Healthcare and a member of the adjunct faculty at Boston University. He also lends his time to the editorial boards for the International Journal of Medicine and Public Health, Journal of Brand…

London, 21 November 2011 -- Newcomers to the field of medical device regulation in Europe have a new guide to steer them through the maze of obligations and requirements. The Journal of Medical Device Regulation (JMDR) has released an update of its best-selling publication entitled A Beginners' Guide to the European Medical Devices Directive (MDD). The Guide is prepared and written by RA expert Haroon Atchia from Quality First International. Haroon, a well-known…

London, 28 April 2011 – No regulations on the own-brand labelling of medical devices exist in the European Union, which is the essence of the problem elucidated in an article published in the May 2011 issue of the Journal of Medical Device Regulation (JMDR). The article is entitled ‘A Confusing Lack of Regulatory Provisions for Own-Brand Labelling of Medical Devices in Europe’ and is written by Haroon Atchia, a member of the…

10 August 2010 – The Journal of Medical Device Regulation (JMDR) has published a new, 8 page publication entitled, Medical Device Regulatory Requirements in South Korea. South Korea is emerging as a prominent medical device market. With a growing gross domestic product, and rising per capita healthcare expenditure, its medical device market can be lucrative for foreign manufacturers. In fact, imports account for the vast majority of the total market. Once the strategy of how…

London, 5 October 2009 – Global Regulatory Press has published a guidance document entitled 'Principles and Practice of Medical Device Classification'. The guidance document 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…

JMDR: Future Revision of the European Medical Devices Directives London, 8 July 2008 – In its upcoming August 2008 issue, the Journal of Medical Device Regulation (JMDR) will publish an article entitled "Future Revision of the European Medical Devices Directives", written by Dr David Jefferys, a member of the JMDR's Editorial Advisory Board and Head of Global Regulatory, Senior Vice President, Eisai Europe Ltd, London, UK. In May 2008, the European Commission…

London, 30 August 2007 -- The amendments to the European Medical Device Directive (MDD) are expected to be published in the Official Journal towards the end of 2007 once the legal and linguistic review has been completed and the final text has been adopted. It is vital for companies to know exactly how the MDD has been amended and to understand how to meet its revised requirements. However, an updated…

London, 23 August 2007 -- Several Editorial Advisory Board members of the Journal of Medical Device Regulation(JMDR) are to attend important regulatory conferences throughout the second half of 2007: Haroon Atchia, CEO & Technical Director, Quality First International Ltd, London, UK will be attending 'Topical Issues for Expert Witnesses' run by the Expert Witness Institute in London, UK on 18 September 2007. Rainer Hill, Deputy Director General, BVMed, Berlin, Germany will be making…

London, July 2007 --- The Journal of Medical Device Regulation (JMDR), the international reference source in regulatory affairs for medical devices, announces that Datuk Dr Mukundan Sugunan Pillay, Deputy Director General of Health, Research and Technical Support at the Ministry of Health in Malaysia, has joined its Editorial Advisory Board. The announcement was made today by Victoria Clark, Editor of the quarterly publication, which reaches regulatory professionals in the US, Canada, the…

London, 5 February 2007 -- The Editorial Advisory Board of the Journal of Medical Device Regulation (JMDR) announced today the appointment of Elena Jugo from Cordis Corporation. With 20 years experience in the clinical research, regulatory affairs and quality assurance fields, Elena Jugo currently holds the position of Manager of Regulatory Affairs in Cordis Corporation. Elena joined Cordis 12 years ago as a Quality Assurance Auditor. Later she transferred to the Regulatory…

London, 2 November 2006 -- Rainer Hill, a member of the Editorial Advisory Board of the Journal of Medical Device Regulation (JMDR) and Deputy Director General of BVMed, Berlin, has received the Medical Device Law Award 2006, which is an honorary prize presented annually by the German publishing house pmi Verlag AG. The award ceremony took place on the occasion of the 'German Day of Medical Device Regulation' in Frankfurt/Main, Germany. Rainer…

London, 28 September 2006 -- In the upcoming November 2006 issue, the Journal of Medical Device Regulation(JMDR) will publish an article written by David R Pickard from the UK consultancy Quality First International entitled Ethylene oxide sterilisation validation - How far can the validity of 'piggy-backed' products be stretched?The article examines many crucial issues of so-called piggy-back medical devices, an increasingly-used term in the medical device industry when referring to the addition…

London, 15 June 2006 -- Jorge Garcia, member of the Editorial Advisory Board of the Journal of Medical Device Regulation (JMDR), will attend the 10th Global Harmonisation Task Force (GHTF) Conference in Luebeck, Germany from 28-30 June. Dr Garcia is the chair of GHTF's Study Group 2 and will contribute two presentations at the three-day conference. On Wednesday 28 June 2006, he will participate in the workshop on "Post-production surveillance – available…

London, 15 December 2005 -- Sergio J Gadaleta PhD, former FDA insider, current Director of Worldwide Regulatory Affairs at Ethicon Inc., a Johnson and Johnson Company and one of America's leading authorities on US and EU regulations for medical device and combination products, has been appointed to the Editorial Advisory Board of the Journal of Medical Device Regulation (JMDR). The announcement was made today by Victoria Clark, Editor of the quarterly publication,…

London, 6 December 2005 -- With the appointment of Dr David Jefferys, one of the medical devices industry's most influential and renowned RA specialists joins the Editorial Advisory Board of the Journal of Medical Device Regulation (JMDR). Dr Jefferys is a high-profile guest speaker at industry conferences where he contributes expert statements on current RA issues. He has also made his mark as an opinion leader by participating in various activities for…

London, August 4, 2005 -- Design for patient safety is a central issue for the current UK health Presidency of the EU. The Journal of Medical Device Regulation (JMDR) has published an article written by Dr David Jefferys entitled Beyond Medical Device Vigilance which addresses some of the most crucial issues of current medical device vigilance systems. Vigilance alone is not sufficient to ensure patient safety According to Dr Jefferys, the post-marketing surveillance of…

London, 5 February 2005 -- Editor Victoria Clark announces the launch of a new medical device regulatory journal, the Journal of Medical Device Regulation. The Journal is published by Global Regulatory Press, London, UK, and features an all-professional editorial board with members from medical device authorities, industries and academic institutions. "The mission of this Journal is to publish peer-reviewed articles which contribute to discussions within the community and to offer resourceful…