FREE ARTICLES
Dear Visitor,
You are welcome to download free reprints of publications authored by Donawa Lifescience Consulting staff.
EUROPEAN REGULATORY COMPLIANCE
M.E. Donawa. European Device Regulatory Revolution: A Personal View, European Medical Device Technology, Jun 2010.
M.E. Donawa. Revised European Guidance on Clinical Evaluations: Part 2, European Medical Device Technology, Apr 2010.
M.E. Donawa. Revised European Guidance on Clinical Evaluations: Part 1, European Medical Device Technology, Mar 2010.
M.E. Donawa. New European Device Clinical Requirements: Part 2, European Medical Device Technology, Feb 2010.
M.E. Donawa. New European Device Clinical Requirements: Part 1, European Medical Device Technology, Jan 2010.
M.E. Donawa. New European Guidance on Borderline Products, Medical Device Technology, Sept 2009.
A.J. Vaughan. Environmental Legislation in the EU - What Medical Device Manufacturers Need to Know, Regulatory Affairs Journal, Jan/Feb 2009.
M.E. Donawa. Addressing European Environmental Legislation. Medical Device Technology, Jan/Feb 2009.
R.L. Gray. A Regulatory Primer - Critical Regulatory Issues, Hurdles, Myths, and Realities, Examined, Explored, Explained, The Trendletter, December 2008.
M.E. Donawa. The Evolving Process of European Combination Product Review Part 2. Medical Device Technology Nov/Dec 2008.
M.E. Donawa. The Evolving Process of European Combination Product Review Part 1. Medical Device Technology October 2008.
M.E. Donawa. Addressing US and European Device Testing Requirements. Medical Device Technology September 2008.
M.E. Donawa. New Italian Device Registration Requirements. Medical Device Technology May/Jun 2008.
R.L. Gray. Revised EU Directives: Many Changes in Store. Medical Device & Diagnostic Industry Feb 2008.
M.E. Donawa. Scope of the European Medical Device Directives. Medical Device Technology Jan/Feb 2008.
M.E. Donawa. Implementing New European Vigilance Requirements. Medical Device Technology Nov/Dec 2007.
M.E. Donawa. Competent Authority Conference on Medical Devices. Medical Device Technology Sept 2007.
R.L. Gray. Understanding the Italian Device Registration Process. ABHI Focus, September 2007.
R.L. Gray. Postmarket Vigilance in Europe: New Guidance for Manufacturers. Medical Device & Diagnostic Industry Sept 2007.
M.E. Donawa. Organising European Technical Documentation to Avoid Duplication. Medical Device Technology Apr 2006.
M.E. Donawa. Proposed Amendments to the Medical Devices Directives. Medical Device Technology Jan-Feb 2006.
M.E. Donawa. US and European Postmarket Clinical Data Requirements. Medical Device Technology Mar 2005
M.E. Donawa, European Animal Tissue Directive, Medical Device Technology Jan-Feb 2004
M.E. Donawa, European Medical Device Regulation: A New Era?, Medical Device Technology Dec 2004
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