NOTE: The previous posting and Events webpage was April 18, 2013 for the date of this presentation. FX Conferences had to change the date of the presentation for unforeseen circumstances and so it now will be on May 2, 2013 (Thurs)
Presentation on IEC60601-1, 3rd edition, Amendment 1 and its Impact on Users
Leo Eisner will be speaking on “IEC 60601–1, 3rd Edition, Amendment 1 and its Impact on Users” at an FX Conferences event on May 2, 2013 (Thurs) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). You don’t have to
Med Electronic Dvc Soln’s Trade Pub’ed Article by Leo Eisner on FDA Home Use Draft Guidance Doc
The FDA’s Home Use Draft Guidance Document has drawn a lot of attention since it was published on 12 Dec 2012. The article that the Medical Electronic Device Solutions (MEDS) Trade Publication released on February 2013 is titled FDA Issues Draft
Which 60601-1, 3rd ed. Standard Applicable for FDA?
I have been asked in a variety of flavors if 3rd ed. of IEC 60601-1:2005 and/or 3rd ed. + Amendment 1 (A1):2012 will be required by the FDA and when? The answer isn’t exactly yes or no. The end of
Proposal for FDA Create New Office to Regulate Mobile Apps
11 Feb 2013 – Regulatory Focus (RAPS) News Article indicates that there will be a re-introduced proposal going thru the US Congress, sometime this year, for the FDA’s CDRH to create a new office to Regulate Mobile Medical Device Applications. What