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You are welcome to download free reprints of publications authored by Donawa Lifescience Consulting staff.

EUROPEAN REGULATORY COMPLIANCE

M.E. Donawa interviewed by Amanda Maxwell for Medtech Insight, Guidance Needed To Explain Scope Of MDR’s Confusing Clinical Investigations Clause, October 2019 (subscription required).

M.E. Donawa and S. Pesci. Avoiding delays when conducting medical device clinical or IVD performance evaluation studies in Germany, May 2019.

M.E. Donawa. RoHS Is a RoHS Is a RoHS . . ., European Medical Device Technology, November/December 2013.

M.E. Donawa. The Critical Task of Selecting a Notified Body, Part Two, European Medical Device Technology, September/October 2013.

M.E. Donawa. The Critical Task of Selecting a Notified Body, Part One, European Medical Device Technology, July 2013.

M.E. Donawa. UK Public Consultation on Mew Medical Device Legislation, European Medical Device Technology, Jan/Feb 2013.

M.E. Donawa. Proposed New European Medical Device Regulations, European Medical Device Technology, Nov/Dec 2012.

M.E. Donawa. Proposed Guidance on IVD Clinical Evidence and Performance Evaluation, European Medical Device Technology, Jul/Aug 2012.

M.E. Donawa and R.L. Gray. The Breast Implant Scandal and European Medical Device Regulation, GMP Review, April 2012.

M.E. Donawa. Guidance to Notified Bodies on Checking Clinical Evaluations, European Medical Device Technology, Nov/Dec 2011.

R.L. Gray. The European Medical Device Regulatory Process (in Chinese), China Medical Device Manufacturer, Summer 2011.

C. d'Alessandro. IVD Directive Recast - What's in Store? White Paper, Aug 2011.

M.E. Donawa. European Medical Device Usability Requirements, European Medical Device Technology, Jun 2011.

M.E. Donawa. The Notified Body Consultation Procedure; Part 2, European Medical Device Technology, Feb 2011.

M.E. Donawa. The Notified Body Consultation Procedure; Part 1, European Medical Device Technology, Jan 2011.

M.E. Donawa. Newly Updated European Classification Guidance, European Medical Device Technology, Sept 2010.

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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