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You are here: Home / Nerac Insights / Articles / Ron Sills, M.S. / Updating Technical Files – Is Your Company Ready for a Notified Body Audit?

Updating Technical Files – Is Your Company Ready for a Notified Body Audit?

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Did you miss our recent webcast “Updating Technical Files – Is Your Company Ready for a Notified Body Audit?” Listen to it here!

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    By Ron Sills, M.S., Nerac Analyst Originally Published: June 22nd, 2015 Nerac was approached by several medical device manufacturers after receiving formal citations by their notified bodies for non-conformities in their clinical evaluation reports, specifically pertaining to the state-of-the-art analysis for their products.  This state-of-the-art requirement is specified in the MEDDEV 2.7.1 Rev. 3 document,…
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    Pre-assessment Audit of Technical File By Ron Sills, M.S., Nerac Analyst Originally Published: April 7, 2014 Introduction The ABC Medical Company is a worldwide leader in the design, manufacture and distribution of wound care devices and wound management systems. Their product line includes moist dressings, silver-impregnated dressings, and debridement devices. The products are assembled into…
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  • Preparing for a Notified Body Audit
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    By Ron Sills, M.S., Nerac Analyst, Originally Published: October 3rd, 2014 Is your company ready for an audit by your notified body?  Medical device manufacturers who market devices in Europe (or plan to) must undergo a rigorous certification process through a notified body, who are authorized on behalf of the European Union to ensure that…
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