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Category Archives: Europe

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

Looking for Medical Device EC-REP? (European Authorized Representative)

  In August 2018, I did a survey of some European Authorized Representatives via email.

Posted bySam Lazzara2018-08-082020-04-16Posted inEuropeLeave a comment on Looking for Medical Device EC-REP? (European Authorized Representative)

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

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

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

Europe MDR General Safety & Performance Requirements vs. MDD Essential Requirements

The Annex I “Essential Requirements” of the European medical device directives have been supercharged and reincarnated

Posted bySam Lazzara2017-06-242020-04-16Posted inClinical Evaluation, Design Control, EuropeTags:EU MDR, medical devices, quality management system, quality system

Europe Medical Devices Regulation (MDR) 2017/745 with Table of Contents and Bookmarks

Did you notice that the published regulation does not have a table of contents or bookmarks?

Posted bySam Lazzara2017-06-07Posted inEuropeTags:EU MDR, medical devices

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

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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