EN 60601-1 (2006) + A1 (2013) status for EU MDD Harmonization & Impact of Annex ZA & ZZ are discussed in this blog.
Presentation on EU RoHS2 and Its Impact on the Medical Device Industry
Leo Eisner will be presenting on the topic “RoHS2 and Its Impact on the Medical Device Industry” at an FX Conferences event on 17 Dec, 2013 (Tues) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). You don’t have to
What is the Scope of IEC 60601-1:2005 (3rd edition)?
This blog will help you determine if and how the IEC 60601-1 Standard applies to your medical electrical product. Definitions, third-party testing, etc. discussed. One of the first questions clients ask before a project starts is, “Does this medical electrical product fall
Where is EU headed with Proposed Medical Device Regulations by ENVI?
The answer seems to be in the direction of a US FDA Style review process for some higher class devices (Class IIb & III) which means longer time to market and more hurdles to get past for these types of
South Korea MFDS Amends it’s Medical Devices Act & Will Require IEC 60601-1, 3rd ed + Amendments
There were three major changes to South Korea’s Medical Devices Act and the Enforcement of the Medical Devices Act as of 8 May 2013.