CENELEC FAQ’s page on the EN60601-1 Series of Standards in Relation to the MDD and AIMDD CENELEC has issued a FAQs page on their website to clarify many of the confusing issues surrounding the EN60601 series of standards including the
Eisner Safety Consultants Newsletter #2 Available
ESC Newsletter #2 – Just Released This issue we are focusing on the MDD Amendment 2007/47/EC including our toolkit to make your transition much easier and an interpretative EC guidance on the implementation of 2007/47/EC. These are both great resources
FDA Wades into Social Media Public Mtg Nov ’09
FDA Wades Into Social Media, Finally NPR article on the FDA starting into discussions of how to deal with social media. This article poses some questions that FDA has in mind about the social media sphere.
Japan Roll Out of 3-Tiered Review System for Medical Devices
Japan Rolls Out Three-Tiered Review System For Medical Devices The Gray Sheet article (posted on Medical Devices Today website) on Japan’s roll out of a new three-track medical device review system. The tracks will be brand-new, improved and “me-too” devices.
IOM to Study Premarket Clearance Process for Medical Devices
Institute of Medicine to Study Premarket Clearance Process for Medical Devices FDA Press release, Sept 23, 2009 – The U.S. Food and Drug Administration today announced that it has commissioned the Institute of Medicine (IOM) to study the premarket notification