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Update of May 5 2017 Addition of the Published Documents “EU MDR & IVDR were Published in OJEU TODAY Friday May 5, 2017″ Stop the Presses and add these earth shattering Regulations to your reading list for the next week or
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
On June 1, 2012 Japan issued their national version of IEC 60601-1:2005 (or 3rd ed.). The transition period has started as of June 1, 2012 but I am still determining what products under Japan’s MHLW’s (Ministry of Health, Labour
This article is an update to the June 24, 2011 article “EU EN IEC 60601-1 3rd ed. Request for Issues on the use of the Std for CE-Conformity” On October 1, 2011 the DRAFT “FAQ related to Implementation of EN
Do you have EU transition period questions related to the MDD & AIMDD Harmonized Standard EN IEC 60601-1:2006 (or sometimes known as 3rd edition of EN IEC 60601-1), its’ collaterals (EN IEC60601-1-XX) and its’ particulars (EN IEC 60601-2-XX) standards? If