Discussion: View Thread

  • 1.  GSPR Ownership

    Posted 28-May-2021 15:00
    Curious as to which function within a medical device organization (i.e. Design, Quality, Manufacturing, Regulatory, etc.) typically "owns" the creation and maintenance of GSPR for MDR.

    ------------------------------
    Geoff Wagner

    ------------------------------


  • 2.  RE: GSPR Ownership

    Posted 29-May-2021 14:09
    Edited by Pamela Stogsdill 29-May-2021 14:09
    I cannot speak to what is 'typical', but for our organization the Regulatory group creates the template and the Engineering group (Design in your list) completes it for each product family.

    ------------------------------
    Pamela Stogsdill
    Regulatory and Quality Specialist
    ------------------------------

    Original Message


  • 3.  RE: GSPR Ownership

    Posted 30-May-2021 21:11
    In our organization, Regulatory has full ownership of the GSPR throughout the product lifecycle- creating/maintaining template, creating/maintaining the product specific record.
    Jackie



    Original Message


  • 4.  RE: GSPR Ownership

    Posted 01-Jun-2021 09:36
    Edited by Geoff Wagner 01-Jun-2021 09:35
    Thank you for the response, Jackie! Do you mind sharing why Regulatory? The reason I'm asking my question is we are trying to determine who should own in my organization. I could see both ways - design has the product knowledge, regulatory has the compliance knowledge - I don't know how to break the tie.

    ------------------------------
    Geoff Wagner
    United States
    ------------------------------

    Original Message


  • 5.  RE: GSPR Ownership

    Posted 01-Jun-2021 09:47
    Sure. Regulatory creates and maintains the tech file, compiling information from the 510k and DHF. Regulatory collaborates with R&D to identify standards relevant to the product early in the design process. The R&D trace matrix includes a x-ref to the standards as well as the V&V test reports. Regulatory can basically take that trace matrix and plug the design references into the GSPR. 
    Hope that helps,
    Jackie



    Original Message


  • 6.  RE: GSPR Ownership

    Posted 02-Jun-2021 01:17
    Took a look through a few things like this: https://www.bsigroup.com/LocalFiles/es-MX/dispositivos-medicos/General_Safety_and_Performance.pdf

    Didn't see anything that would steer one way or another.

    On the other hand, maybe I'm a bit confused, are you asking which way you should setup your procedures for handling this? Shouldn't the 'responsibility' lie with the Product Owner?

    Best wishes,


    LARRY GRYZIAK
    VP QUALITY AND REGULATORY
    ORTHOGONAL.IO       630.637.0527
    CHICAGO • SAN FRANCISCO







    Original Message


  • 7.  RE: GSPR Ownership

    Posted 30-Aug-2021 17:09
    Hi Larry,

    Thanks for the response. What I am asking is - if you had a line on a RACI (responsible for execution, accountable, consulted/contribute, informed) matrix for GSPR what functional group (i.e. Regulatory, Quality, Design, etc.) should the R be placed next to...

    I think "product owner" is too generic and will not work in my organization for several reasons. In my organization the product owner is the product-line manager. They do not have the technical expertise nor the ability to populate this document. 

    Hopefully that helps clarify.

    ------------------------------
    Geoff Wagner
    Coralville IA
    United States
    ------------------------------

    Original Message