www.fdanews.com/articles/146213-ghtf-proposes-risk-based-tool-for-harmonizing-device-audits
GHTF Proposes Risk-Based Tool for Harmonizing Device Audits
May 7, 2012
Cross-border sharing of devicemaker audit results should be easier, thanks to a standardized nonconformity grading system developed by the Global Harmonization Task Force’s (GHTF) Study Group 3. The proposed document, posted to the GHTF website April 23, does away with the classification of “major” and “minor” conformities and instead introduces a two-step approach to help inspectors determine and communicate the degree of risk associated with a particular deviation.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor