Progress Report Archive
Check out previous issues of LNE/G-MED's monthly newsletter, Progress Report. Each issue contains the latest guidance on European medical device directives, Canadian medical regulation and other critical news for medical device manufacturers. If you missed an issue or wish to review a topic, simply select the issue date below to download a PDF version.
Read the most recent issue on "Tec File Evaluation" here.
Previous Issues
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February 2012 : A Notified Body’s Perspective on Post-Market Phase
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January 2012 : IEC 60601 3rd Edition (copy 1)
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December 2011 : Tech File Evaluation
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November 2011 : Simply Switching your Notified Body
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October 2011 : The Future of the IVD Directive
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September 2011 : CE Marking of Own Brand Label Devices:Manufacturer Benefits and Requirements
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April 2011 : Recast of IVDD - Consultation Results
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March 2011 : Sterile Medical Device Packaging
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October 2010 : Will FDA recognize ISO 13485 registration?
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September 2010 : Are Changes Coming to the IVD Directive?
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August 2010 : Software Engineering Applied to Medical Devices: New Requirements of 2007/47/EC
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April 2010 : Usability Engineering Applied to Medical Devices: Re-enforced Requirement Introduced by Directive 2007/47/EC
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February 2010 : Risk Management Applied to Medical Devices: Complying with EN ISO 14971:2009 (copy 1)
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January 2010 : CE Marking of Medical Devices: Prepare for Enhanced Role of “Clinical Evaluation” as an Essential Requirement
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November 2009 : FDA Third Party Inspection Program
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September 2009 : Overview of Recent Guidelines Relative to the European Medical Device Directives
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August 2009 : European Environmental Policy & Impact on Medical Devices
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June 2009 : Impact of Directive 200747/EC on Future CE Marking Audits for Manufacturers of Medical Devices (Excluding IVD)
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May 2009 : European Environmental Policy & Impact on Medical Devices
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March 2009 : Evolution of the ISO 9001 Standard: Changes and Impacts
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