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Eisner Safety Consultants: Qmed Qualified Supplier
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Wearables the rage but are they medical devices?

Guidance documents to help you determine if your Wearable device is a medical device that needs FDA approval or not for US submissions. Wearables may be the rage but what does your company need to do for an FDA medical device submission in the US (or do you even need one from the FDA?) with [...]

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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to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived. [...]

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IEC 60601-1-2:2014 (4th ed.) What is the Impact of this Puzzle on Your Product Design?

This is a summary of some of the changes in EMC requirements of IEC 60601-1-2, 4th ed. & a discussion of timing of requirements in different world regions. Darryl Ray, of Darryl Ray EMC Consulting, provided the technical and regulatory content for this Blog Post.  Thx for your insight Darryl! What is the impact of [...]