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Monthly Archives: July 2017

Europe Clinical Evaluation Guidelines SmackDown

The European Commission’s medical device conniption reached a frenzied pitch with the release of the Medical Devices Regulation (MDR) 745/2017 in May 2017.

Posted bySam Lazzara2017-07-252020-04-16Posted inClinical Evaluation, EuropeTags:EU MDR, medical devices

Risk flowchart you won’t find in EN ISO 14971:2012

If you are concerned about marketing your devices in Europe, don’t be fooled by the flowchart in the international version of ISO 14971:2007. It is WRONG.

Posted bySam Lazzara2017-07-02Posted inEurope, risk managementTags:ISO 14971, medical devices, quality management system, risk management

What standards apply to my medical device?

This should be one of the first questions asked during the medical device development process.

Posted bySam Lazzara2017-07-02Posted inDesign Control, StandardsTags:medical devices, quality management system, Standards

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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