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Monthly Archives: March 2011

Pyrogenicity – Dead Bugs?

I am not a microbiologist but I play one on TV!

Posted bySam Lazzara2011-03-31Posted inquality system, SterilizationTags:medical devices, quality management system, quality systemLeave a comment on Pyrogenicity – Dead Bugs?

Independence Matters

Independence is the basis for judicial systems and sporting matches. And for quality systems, it is generally accepted that personnel who are independent of an activity are more objective (impartial) than persons who are directly responsible for the success of the work. 

Posted bySam Lazzara2011-03-31Posted inISO 13485, quality system, US FDA RegulationsTags:medical devices, quality management system, risk managementLeave a comment on Independence Matters

Author

  • 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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