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

Nonconformity Grading System for Regulatory Purposes and information Exchange

This document is intended for regulatory authorities and auditing organizations. It introduces a standardized nonconformity grading system for regulatory purposes with a Regulatory Audit In-formation Exchange Form providing consistent audit information in order to enable exchange among regulatory authorities. Currently, the significance of a nonconformity related to a medical device manufacturer’s Quali-ty Management System (QMS) may vary between regulatory authorities and auditing organiza-tions. All parties will benefit from the use of a standardized and transparent grading system of QMS nonconformities. This will build the confidence necessary for the potential mutual ac-ceptance of the results of a regulatory audit.

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.

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


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

    Build Business Value by Proactively Listening to Your Customers’ Complaints


       January 19, 2021   |   02:00 - 02.30 PM EST

    Follow Us