Eisner Safety Consultants: Qmed Qualified Supplier

Join Us @ RAPS Regulatory Convergence Discuss Wearable Devices 26 Oct ’15

Join Us at RAPS Regulatory Convergence Conference on Monday October 26, 2015 to Discuss Wearbale Devices Topic: “Wearable Devices: How to Make Them Safe and Adhere to Regulations” Presenters: Leo Eisner & Mary Weick-Brady of Eisner Safety Consultants and Bakul Patel of OC, CDRH, FDA Session Leader: Seth Goldenberg, PhD, director, Global Regulatory Strategy, NAMSA When: October 26, 2015 […]

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 […]

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 […]