Quick Contact : 408-458-8343
Select Page
FacebookGoogle BookmarksTwitterLinkedInPinterestEmail

This document has been prepared by Study Group 4: Auditing which was convened by the Global Harmonisation Task Force. The members of this group were auditing experts from, or acting on behalf of, regulatory bodies and representatives of the medical device manufacturing industries from Australia, Canada, Europe, Japan and the USA. A list of the organisations represented on the Study Group can be found in Annex A. The incorporation of quality system requirements, based on ISO 9001/9002/9003, into regulations applicable to manufacturers of medical devices, provides the opportunity for developing mechanisms that would lead to global harmonisation.

Download

Please fill the form below to access the resource.







    By submitting this form you agree that we store and process your personal data as per our Privacy Policy. We will never sell your personal information to any third party.

    Webinars
    x
    Upcoming
    FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

    Register

       January 27, 2021   |   01:30 - 02.15 PM EST

    Follow Us