Transcription of GHTF SG4 - Guidelines for Regulatory Auditing of …
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GHTF SG4 - Guidelines for Regulatory Auditing of …
GHTF/SG4/N84:2010 FINAL DOCUMENT Global Harmonization Task Force Title: Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 5: Audits of Manufacturer Control of Suppliers Authoring Group: Study Group 4 of the Global Harmonization Task Force Date: August 27, 2010 Dr. Larry Kelly, GHTF Chair The document herein was produced by the Global Harmonization Task Force, which is comprised of representatives from medical device Regulatory agencies and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development.
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 5: Audits of manufacturer control of suppliers
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