Regulatory Open Forum

 View Only

  • 1.  Certified quality system for clinical trials Yes/No?

    This message was posted by a user wishing to remain anonymous
    Posted 23-Nov-2020 09:12
    This message was posted by a user wishing to remain anonymous

    Hi all, 

    Working essentially with small and start up companies, we are used to develop a quality system in compliance with ISO 13485 for medical devices, but much more efforts should be invested to have it certified by an official body. 
    I don't see the certification as a "must" for pilot clinical trials (even in the US) all the time the internal audits happen. 
    What is your opinion?
    Can FDA or European competent authority ask for quality system certification for pilot studies?


  • 2.  RE: Certified quality system for clinical trials Yes/No?

    Posted 24-Nov-2020 09:25
    Hello,

    This would be easier to answer if you share your trial responsibilities.  If there is a lab involved, they must be certified.  ​

    ------------------------------
    Gretchen Upton CQA, CCRP, RAC
    RA/QA
    TX
    United States
    ------------------------------

    Original Message


  • 3.  RE: Certified quality system for clinical trials Yes/No?

    Posted 24-Nov-2020 09:54
    As a follow up, this guidance may help you: https://www.fda.gov/media/75381/download

    Or these:  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trials-guidance-documents​

    ------------------------------
    Gretchen Upton CQA, CCRP, RAC
    RA/QA
    Helotes TX
    United States
    ------------------------------

    Original Message


  • 4.  RE: Certified quality system for clinical trials Yes/No?

    Posted 24-Nov-2020 10:45
    I worked for several years at the VA for medical device research (IDE). FDA considered only 21 CFR 820.30 (Design Controls) as a formal requirement.

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device

    DOD/DARPA/Dept Veterans Affairs Design Controls in Research

    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 5.  RE: Certified quality system for clinical trials Yes/No?

    Posted 26-Nov-2020 02:09
    Hello,

    For US, investigational devices meant to be used in a clinical study and approved under an investigational device exemption (IDE) are exempt from the Quality System (QS) regulation, except for the design control requirements under §820.30.
    For EU you will need to show that the device in question conforms to the general safety and performance requirements of MDR apart from the aspects covered by the clinical investigation. See for more details Annex XV of MDR. 

    Regards,

    ------------------------------
    Ioana Ulea
    Regulatory Affairs Professional
    ------------------------------

    Original Message


  • 6.  RE: Certified quality system for clinical trials Yes/No?

    Posted 27-Nov-2020 11:28
    Edited by Lance Tovar 01-Dec-2020 16:18
    Hi,

    To simply answer your question... NO, your QMS does not need to be certified. If you have labs, those always have to be certified. An FDA auditor won't care about your ISO certification. They will check to see if you QMS is compliant with 21 CFR 820. However, having your QMS certified by an agency is highly recommended. 

    Hope this helps.
    Lance

    ------------------------------
    lance tovar
    Roy UT
    United States
    ------------------------------

    Original Message


Related Content