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
IEC 60601 Medical Electrical Equipment Classifications: FAQ’s
IEC 60601 medical electrical equipment classification frequently asked questions are discussed in this blog. Why do I need to classify my product for IEC 60601-1, 3rd ed.? – The standard says you have to classify“…ME EQUIPMENT, or parts thereof, including applied parts…” as
When will FDA Issue Guidance Document on AAMI ES 60601-1, 3rd ed. + Amendment 1?
That’s a really good question and the answer is sooner than I would have thought. Especially since the draft guidance has been pushed forward and then pushed back aside so many times internally at FDA it is really hard to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