Medical Device Industry – Page 12 – Eisner Safety Consultants

MEDDEV 2.12-1 Guidelines on Medical Devices Vigilance System Updated to Rev 8

This blog post is thx to our associate Christine Ruther and a special thx goes out to Helene Spencer. MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System was updated in January 2013. The revised guidance is applicable as of July

Reminder Presentation on IEC60601-1, 3rd edition, Amendment 1 & its Impact on Users on 2 May ’13

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

NB-MED issues FAQ on Implementation of EN62304:2006 w.r.t. MDD, V1.0

18 April 2013 – The NB-MED EN62304:2006 issues team released their first official version (V1.0) dated 5 April 2013 of this importnat implementation document in regards to EN 62304 with respect to the Medical Device Directive 93/42/EEC on the NB-MED website. EN

Date Change for Presentation on IEC60601-1, 3rd edition, Amendment 1 and its Impact on Users

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)