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MEDICAL COMPLIANCE SEMINAR Thursday, May 18, 2017 Seminar Topics: Current guidance around Medical Electrical Equipment for FDA 510(k)s & Health Canada IEC 60601-1 series: Intro to IEC 60601 -1 series with Collateral & Particular Standards Design & compliance to IEC 60601-1
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.
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
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
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