This post discusses that EN60601-1:2006+Amendment 1 (A1):2013 has finally been Harmonized under the MDD. This is really big news that many of us in the medical industry have been waiting to hear occur for quite awhile. What’s The Big News
Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ
EN 60601-1 (2006) + A1 (2013) status for EU MDD Harmonization & Impact of Annex ZA & ZZ are discussed in this blog.
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