Eisner Safety Consultants: Qmed Qualified Supplier

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 […]

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 […]

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 […]

AS/NZS IEC 60601.1:2015 (Edition 3.1) Just Published

Just Published on 23 Sept 2015 the Australian / New Zealand Joint Standard AS/NZS IEC 60601.1:2015 which is based on the complete IEC 60601-1, edition 3.1:2012 (identical).  The only differences are in the AS/NZS IEC 60601-1:2015 the preface states to a) replace the international standards references with references to Australian or Australian / New Zealand Standards, b) replace in the source […]

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 […]