11 Feb 2013 – Regulatory Focus (RAPS) News Article indicates that there will be a re-introduced proposal going thru the US Congress, sometime this year, for the FDA’s CDRH to create a new office to Regulate Mobile Medical Device Applications. What
IEC TR 62348:2012 Added in Assessment of impact of most significant changes of IEC 60601-1:2005 Amendment 1
A very useful document was recently released to be a summary of the significant and moderate changes made to IEC 60601-1:2005 based on Amendment 1 (A1) of IEC 60601-1. This is an excellent resource (IEC TR 62348:2012, published 12 Dec
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