Eisner Safety Consultants: Qmed Qualified Supplier

Welcome Mary Weick-Brady to Eisner Safety Consultants

I am thrilled to announce our latest addition to the Eisner Safety Consultants team Mary Weick-Brady recently joined our team and will help us support a growing need for the Wearable Medical Devices and the Home Use Medical Markets. Ms. Weick-Brady comes with tremendous experience in the Home Use space and with respect to patient labeling and will be a […]

Standards Reconnaissance Subscription Service Coming Soon

Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines?  How much time does it take to put this list together and how much effort does it take to keep the list updated? If this is a struggle for […]

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 that to determine if Wearables are medical devices you must a) review the definition of […]

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 Valley.  It would be great to meet you at this workshop or the entire conference […]

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 device submission in the US (or do you even need one from the FDA?) with […]