Leo Eisner – Eisner Safety Consultants

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).

MD&DI Interview Leo Eisner re:NB-MED Draft Doc EN60601 Implementation for EU

leoeisner — Tue, 11 Oct 2011 19:15:04 +0000

On Oct 6, 2011 MD&DI (Heather Thompson) interviewed Leo Eisner of Eisner Safety Consultants in regard to his blog posting on the NB-MED draft document “FAQ related to implementation of EN 60601-1:2006 Clarification of open issues”.

Two Conf’s on 60601 Series of Stds Mar 3 & 4th

leoeisner — Mon, 28 Feb 2011 13:00:23 +0000

Come join Eisner Safety Consultants at one or both conferences March 3 & 4th. Both are related to the 60601 series of standards.

On March 3rd join FX Conferences and Leo Eisner to learn about the home healthcare environment and the proposed emergency medical services standards, respectively IEC 60601-1-11 & IEC 60601-1-12 (hopefully). More information can be found on our blog post on this topic.

On March 4th join Leo Eisner in Foster City, CA as he & several other presenters focus on the topic of “Evolving Risk-Based Regulatory Requirements” for a whole day workshop put on by RAPS (SF Bay Area Chapter) & ASQ (Biomedical Division Northern CA Discussion Group). Leo will be presenting on the 3rd ed. of IEC 60601-1, the series of standards, and also the impact of change on the medical device industry. Other topics will include Usability & Human Factors verification, validation, and regulatory requirements; and Clinical evaluation & investigation regulatory requirements. More information can be found on our blog post on this topic.