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Monthly Archives: April 2015

Damn…we failed verification testing!

 I can think of 3 options when engineering specification (design verification spec) is not met.

Posted bySam Lazzara2015-04-01Posted inDesign Control, quality systemTags:Design Control, medical devices, quality management system, quality systemLeave a comment on Damn…we failed verification testing!

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  • Sam Lazzara
    • ISO 14971:2019 & Europe MDR Risk Management Process Flow
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    • Clinical evaluation & investigation in Europe MDR
    • Europe Clinical Evaluation Guidelines SmackDown
    • Risk flowchart you won’t find in EN ISO 14971:2012
    • What standards apply to my medical device?

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