Regulatory Open Forum

 View Only

  • 1.  EU GSPR, Health Canada and TGA Essential Principles Checklist Matrix

    This message was posted by a user wishing to remain anonymous
    Posted 27-Oct-2022 08:04
    This message was posted by a user wishing to remain anonymous

    Hello Medical Device Experts,

    Can you please share a consolidated matrix covering EU GSPR, TGA Essential Principles Checklist, and Health Canada Essential Requirements Checklist?

    Thank you.


  • 2.  RE: EU GSPR, Health Canada and TGA Essential Principles Checklist Matrix

    Posted 28-Oct-2022 08:10
    Hello Anonymous,

    I am going to just reply only on my behalf. 

    I think you are going to have to develop that yourself.  We are put time and effort into the things we create.  Why would we give it all away,?

    Doing it yourself actually makes you read THE REQUIREMENTS.  Don't skip that step!

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 3.  RE: EU GSPR, Health Canada and TGA Essential Principles Checklist Matrix

    Posted 28-Oct-2022 11:52
    Hi, Ginger, I agree with you in recommending people to do a checklist themselves. As each medical device is different in its own way, and while you generate the checklist yourself, you will also justify whether the requirement is relevant to your own product and whether there is a gap to fill:-)

    ------------------------------
    Chunying Meng RAC
    Oxford
    United Kingdom
    ------------------------------

    Original Message


Related Content