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Category Archives: Risk Management

ISO 14971:2019 & Europe MDR Risk Management Process Flow

Trying to understand the “state of the art” in medical device risk management? This diagram attempts to distinguish between ISO and European requirements.

Posted bySam Lazzara2020-02-10Posted inEurope, Risk Management, risk management, StandardsTags:EU MDR, medical devices, risk managementLeave a comment on ISO 14971:2019 & Europe MDR Risk Management Process Flow

Clinical evaluation & investigation in Europe MDR

Want a good career with lots of job security? Learn how to perform clinical evaluations or run clinical investigations.

Posted bySam Lazzara2017-08-16Posted inClinical Evaluation, Europe, Risk ManagementLeave a comment on Clinical evaluation & investigation in Europe MDR

Quality System Process Risk Management (ISO 13485:2016)

ISO 13485:2016 has a broader view of risk management than in the past. 

Posted bySam Lazzara2017-06-13Posted inquality system, Risk ManagementTags:ISO 13485, medical devices, quality management system, quality system, risk management

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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