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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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Case Study for Health Canada Device License & 11 Steps to Obtain CMDCAS Certification






Rob Packard, a Quality System & Regulatory expert of Medical Device Academy, was gracious enough to allow us to post these articles he wrote recently on Canadian Medical Device Regulations.  Thx Rob! The first article is a hypothetical case study that explains the process of obtaining a Health Canada Medical Device License. The second and third […]

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CAN/CSA C22.2 No. 60601 Standard Changes






Reminder post – withdrawal of CAN/CSA C22.2 No. 601.1-M90+A1+A2 is on June 30, 2014 & CAN/CSA-C22.2 No. 60601-1:14 was recently published        

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CAN/CSA C22.2 No. 60601-1:14 (Harmonized with Ed. 3.1) Recently Released






This blog reviews the release of Canadian Standard CAN/CSA C22.2 No. 60601-1:14 & where accessible (Safety Test Agencies vs Health Canada) Recently Released CAN/CSA C22.2 No. 60601-1:14

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IMDRF Draft Guidance Doc’s Out for Comment: UDI & 3rd Party Audits






The  International Medical Device Regulators Forum (IMDRF) has been really busy of late, which is a good thing as many in the medical device industry are still wondering if the IMDRF will live up to the “Big Shoes” that the GHTF left behind when it was decommissioned in the last. In another post I will […]