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

leoeisner — Tue, 29 Sep 2015 06:43:50 +0000

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 (Monday), 3:30PM – 5:00PM Eastern

Where: RAPS Regualtory Convergence Conference (Register to Join the Conference)

As the use of medical device wearables continues to grow, how does the medical device industry stay abreast of the proper regulations and standards that apply to these devices when seeking clearance? Industry and agency experts will discuss applicable regulations and standards and what is required for regulatory submissions for medical device wearables. Learn to better identify the applicable standards and regulations to consider for medical device wearables during regulatory submission.

If you need additional support for Wearable Medical Devices and Home Use Medical Devices email Leo Eisner at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

Welcome Mary Weick-Brady to Eisner Safety Consultants

leoeisner — Tue, 29 Sep 2015 05:49:46 +0000

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 fantastic addition to our company. With 25 years of experience at the FDA, and over 30 years of experience as a registered nurse, including 6 years as a home health care nurse, Ms. Weick-Brady is able to provide training on home use policy, assist with premarket submissions intended for home use, and help industry understand the regulatory process. As Mary & I were talking about her joining the Eisner Safety Consultants team her excitment to help with the Home Use market and users of these devices seemed endless. She made a point that she is concerned for the end user, particularly the patient. This is clear by her statement to me: “I am (Mary) invested in having an understandable format of instructions for use and to make sure these instructions for use are accessible and usable by the end user. She is also invested in making sure medical devices are being developed with the end user in mind as a useful and usable part of healthcare in non-clinical environments.”

Please welcome Mary Weick-Brady to our growing team that can support your medical device policy, regulatory, safety certification, and quality system needs. To find out more about her background and the rest of the Eisner Safety Consultants team members please check out our Associates web page.

Mary Brady – Eisner Safety Consultants

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

Welcome Mary Weick-Brady to Eisner Safety Consultants