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Tips for Success When It Comes to IEC 60601-1 – Podcast






Jon Speer, founder and VP of QA/RA @ greenlight.guru and I, Leo Eisner, Principal Consultant of Eisner Safety Consultants, had a dynamic & interesting conversation that we are sharing as a podcast with you on tips for success when it comes to IEC 60601-1. Eisner Safety Consultants has teamed up with greenlight.guru, a specialized electronic Quality Management System […]

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Home Use Medical & Wellness Devices Article by Leo Eisner






Near the end of writing this article I had an unfortunate incident that I personally had to use a home use medical devices for 3 weeks of IV antibiotics (syringe pump – like an infusion pump but with a syringe instead of an IV bag) after a knee joint infection that I had to have emergent surgery & […]

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CAN/CSA C22.2 No. 60601-1:14 Added to Health Canada’s List of Recognized Standards






This post discusses Health Canada’s most current List of Recognized Standards for Medical Devices effective 31 Aug 2015. Health Canada updated their list of Recognized Standards for Medical Devices on August 31, 2015.  The changes included additions, updates and removals to the listing.  Part of the update was adding the Canadian National Version of IEC 60601-1, edition 3.1 […]

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Standards Reconnaissance Service Coming Mid Oct ‘15 to Eisner Safety Consultants






Do you want to ensure standards compliance to meet quality & regulatory requirements? Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed markets of US, EU, etc. but also the emerging markets (e.g. China, Brazil, etc.) Our […]

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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 […]