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
Wearables the rage but are they medical devices?
Guidance documents to help you determine if your Wearable device is a medical device that needs FDA approval or not for US submissions. Wearables may be the rage but what does your company need to do for an FDA medical
OSHA NRTL’s approved for AAMI ES 60601-1 3rd edition + Amendment 1 (or edition 3.1)
This post discusses NRTL’s approved for AAMI ES 60601-1 3rd ed. + A1 & can issue NRTL Marks vs which are in process. There has been a lot of activity from OSHA with respect to the NRTL (Nationally Recognized