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Category Archives: Notified Bodies

Notified Body Selection Guide

So many people ask me for Notified Body (NB) selection advice that I decided to get a little organized. 

Posted bySam Lazzara2018-03-062020-04-16Posted inEurope, Notified BodiesTags:EU MDR, medical devicesLeave a comment on Notified Body Selection Guide

Notified Body Sleuthing

Unfortunately, there is currently no centralized database to search Notified Bodies and their Client companies. Here are some ideas for how to go about this.

Posted bySam Lazzara2015-02-17Posted inEurope, Notified Bodies, quality systemTags:medical devices, quality management system, quality systemLeave a comment on Notified Body Sleuthing

Notified Body Selection Advice

Notified Bodies are no longer fighting for your attention – you need to fight for their attention!

Posted bySam Lazzara2014-01-23Posted inEurope, Notified BodiesTags:medical devices, quality management system, quality systemLeave a comment on Notified Body Selection Advice

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  • Sam Lazzara
    • ISO 14971:2019 & Europe MDR Risk Management Process Flow
    • Quality System Documents & Services
    • ISO IEC EN Standards Hacks, Tips, Tricks
    • Looking for Medical Device EC-REP? (European Authorized Representative)
    • Sam’s List of FDA Registered Contract Manufacturers & Sterilizers in SF Bay Area
    • Notified Body Selection Guide
    • 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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