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Great Resource – Current/Draft IEC 60601/80601 Series of Stds & Test Rprts Now Available

We recently updated our website to make it easier for you to check the current IEC 60601 standards and the test report forms (TRFs) and you can check the status of draft standards and where in the process they are.  

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 2013.   The revision contains clarifications rather than significant changes.

EU MDD, AIMDD, IVDD Harmonized Standards (EN980 & EN ISO 15223-1) Ooopppss!

The EN 980 Symbols for use in the labeling of medical devices standard was mistakenly taken off of the EU Harmonized List of standards on the Jan 24, ’13 release and EN ISO 15223-1 Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General […]

New LinkedIn Group on IEC 60601 Medical Electrical Equipment & Systems

A new LinkedIn group has been formed thx to the support of the IEC (International Electrotechnical Commission)*.  The group name is the IEC 60601 series of standards on Medical Electrical Equipment.  This group is not just about the 3rd edition of IEC 60601-1 but about the whole series of IEC 60601 series of standards and […]

GHTF has transitioned to IMDRF

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’s” 20 years and the aim is to “accelerate international medical device regulatory harmonization […]