Leo Eisner will be speaking on Medical Device Wearables and the Current Thinking from FDA with respect to myriad of new guidance documents that may apply to your devices. This presentation is being offered 2 times in July (Tuesday July
IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3rd ed. Published
IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3rd ed. Published This post discusses the recently published Guidance IEC TR 60601-4-3:2015 that issues interpretations of IEC 60601-1, 3rd ed. and edition 3.1. The technical report tiled IEC TR 60601-4-3:2015
Guidelines for Medical Device Safety Testing – AAMI TIR62354:2015
Our Associate Dale Hallerberg provided a short note about this recently published AAMI Guideline on Medical Device Safety Testing. AAMI has published Technical Information Report (TIR) 62354:2015 “General testing procedures for medical electrical equipment”. This report is available from AAMI
Part 2 – Wearables the rage but are they medical devices?
Part 2 of series Posts – “General Wellness” & “Medical Device Accessories” FDA Guidances in regard to Wearables. Join us @ 10X conference & learn more From the previous “Wearables the rage but are they medical devices?” blog post I indicated
510(k) Workshop at 10X Conference
On May 4, 2015 in San Diego, I, Leo Eisner, am presenting along with 2 other experts in the field on the 510(k) process. The 10X Conference is from May 4 – 6, 2015 at the Hilton San Diego Mission