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Eisner Safety Consultants: Qmed Qualified Supplier
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Guidelines for Medical Device Safety Testing – AAMI TIR62354:2015

Our Associate Dale Hallerberg provided a short note about this recently published AAMI Guideline on Medical Device Safety Testing. AAMI has published Technical Information Report (TIR) 62354:2015 “General testing procedures for medical electrical equipment”.  This report is available from AAMI at http://my.aami.org/store/SearchResults.aspx?searchterm=62354&searchoption=ALL. This document is identical to the IEC TR 62354:2014 published last September, and gives detailed [...]

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510(k) Workshop at 10X Conference

On May 4, 2015 in San Diego, I, Leo Eisner, am presenting along with 2 other experts in the field on the 510(k) process. The 10X Conference is from May 4 – 6, 2015 at the Hilton San Diego Mission Valley.  It would be great to meet you at this workshop or the entire conference [...]

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BSI White Paper on Human Factors & Usability

Blog focus BSI’s 7th in a series of White Papers for Medical Device, on  Human Factors & Usability Engineering White Paper on The growing role of human factors and usability engineering for medical devices This white paper is on “The growing role of human factors and usability engineering for medical devices”and is focused on “…applying knowledge of [...]

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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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MDD Harmonized List of Standards Website Moves & Medical Device Sector Page Changes

On 2 Feb 2015 the previous site for the List of Harmonized Standards for the MDD and other Medical Device Directives (AIMDD & IVDD) moved to a new location. The old MDD Harmonized Standards Listing used to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived. [...]