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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
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
This article was written by Leo Eisner and is featured in the Journal for Medical Device Regulations in their May 2012 edition. It is the top article on our Featured Articles WebPage. This article is on the National Implementations of
Today (22 MARCH 2012) Health Canada (HC) has issued to manufacturer’s of record (those mfr’s with a HC License to sell & market product in Canada) a NOTICE titled “ADDITIONAL GUIDANCE ON TRANSITION FROM THE SECOND TO THE THIRD EDITIONS
On November 9, 2010 Health Canada’s Therapeutic Product Directorate (TPD) issued an interpretation of the Medical Devices Regulations (Regulations) with respect to electronic labeling (e-labeling) of certain medical devices sold or imported into Canada. This interpretation only covers products for