FDA launches new “Transparency” website http://ow.ly/1DNs4 with lots of info, presentations, etc. But is it good enough for industry?
STERIS System 1 Alternative System 1E Cleared by FDA
STERIS System 1 Alternative System 1E Cleared by FDA April 5, 2010 on STERIS System 1 updates webpage – http://ow.ly/1yvpf
FDA Requires Manufacturers to Include Info on Pediatric Populations
FDA Requires Device Manufacturers to Include Information on Pediatric Populations http://ow.ly/1vJpz
US Devicemakers Given Three Year Transition to IEC 60601-1
Devicemakers Given Three Years to Transition to New Standard From FDA News Devices & Diagnostic Letter March 29, 2010 Devicemakers may have to pay up to 40 percent more to test the safety and effectiveness of electronic devices now that
Eisner Safety Consultants Newsletter #5 Now Online
Eisner Safety Consultants Newsletter #5 Now Online This issue we are going to focus on primarily on IEC/EN 60601-1:2005/2006 as there is some significant news within the last few weeks and more to come really soon. Also, we would be