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
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
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
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
FDA & EU MDD / AIMDD / IVDD Updated Standards Lists
Recently the FDA (United States) has released its latest List of Recognized Consensus Standards & the EU (European Union) has released updated lists of Harmonized Standards for the MDD (Medical Device Directive), the AIMDD (Active Implantable Medical Device Directive), and