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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
As of November 2012 the GHTF (Global Harmonization Task Force) is no longer operating as evidenced by several pieces of information. In it’s place the International Medical Device Regulators Forum (IMDRF) is working to “build on the strong foundation of
The GHTF has been around for almost 20 years and is in the process of disbanding to become a more Regultor focused group called the International Medical Device Regulators’ Forum (IMDRF). In the Eucomed 18 Nov 2011 newsletter article they
On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October
The 21st Annual AAMI/FDA International Conference on Medical Device Standards & Regulation, is on March 23 – 24, 2011 at the Hyatt Dulles Hotel in Herndon, VA. Leading standards experts discuss these issues http://ht.ly/43C6V