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
IEC 60601-1-2:2014 (4th ed.) What is the Impact of this Puzzle on Your Product Design?
This is a summary of some of the changes in EMC requirements of IEC 60601-1-2, 4th ed. & a discussion of timing of requirements in different world regions. Darryl Ray, of Darryl Ray EMC Consulting, provided the technical and regulatory
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 Especially since the draft guidance has been pushed forward and then pushed back aside so many times internally at FDA it is really hard to