New Demands Edge Closer for Clinical Trial Safety Reporting in the EU
This article was originally published in RAJ Devices
Executive Summary
The implementation deadline of 21 March has gone by and new safety reporting requirements for clinical investigations are now in place throughout the European Union.
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New Demands Edge Closer for Clinical Trial Safety Reporting in the EU
The implementation deadline of 21 March has gone by and new safety reporting requirements for clinical investigations are now in place throughout the European Union.
The 2009 Revision of ISO 14155: A True Worldwide Guidance for Medical Device Companies?
ISO 14155, the international standard covering medical device clinical investigation, has had its controversies over the past two years. An immature revision was brought out in 2008 and was subsequently voted down by many European Union countries; when it emerged that it had attracted no fewer than 1,100 comments, it was clear that something was wrong.
The 2009 Revision of ISO 14155: A True Worldwide Guidance for Medical Device Companies?
ISO 14155, the international standard covering medical device clinical investigation, has had its controversies over the past two years. An immature revision was brought out in 2008 and was subsequently voted down by many European Union countries; when it emerged that it had attracted no fewer than 1,100 comments, it was clear that something was wrong.