2 янв. 2004 г. Guidance is provided for reaching decisions on whether to validate or not. Page 5. GHTF Study Group 3 - Quality Management Systems. Process ...
16 мая 2012 г. This document was produced by the Global Harmonization Task Force a voluntary international group of representatives from medical device ...
2 нояб. 2012 г. GHTF would seek to evolve beyond convergence of regulatory requirements to embrace mutual acceptance of common data submissions pre-market ...
11). Page 5. Guidance on corrective action and preventive action and related QMS processes. GHTF/SG3/
Authoring Group: GHTF Study Group 3. Endorsed by: The Global Harmonization Task Force. Date: May 20 2005. Abraao Carvalho
Study Group 1 of the Global Harmonization Task Force (GHTF) has prepared this guidance document. Comments or questions about it should be directed to either the.
GHTF/SG5/N8:2012 Clinical evidence for IVD medical devices – Clinical Performance Studies for In Vitro Diagnostic Medical Devices. 4.0 Definitions. Diagnostic
18 февр. 2010 г. The document herein was produced by the Global Harmonization Task Force which is comprised of representatives from medical device ...
9 нояб. 2012 г. When submitting a guidance document to the GHTF Steering Committee for endorsement the Study Group should confirm it has made the comparison ...
The objective of the Global Harmonization Task Force (GHTF) is to encourage convergence at the global level in the evolution of regulatory systems for medical
2004?1?2? Guidance is provided for reaching decisions on whether to validate or not. Page 5. GHTF Study Group 3 - Quality Management Systems. Process ...
2012?11?2? GHTF/SG5/N6:2012. FINAL DOCUMENT. Global Harmonization Task Force. Title: Clinical Evidence for IVD medical devices – Key Definitions and.
Part 5: Audits of manufacturer control of suppliers. GHTF/SG4/N84 R13:2010 Study Group 4 - Final Document. August 27 2010. Page 2 of 8. Table of Contents.
2008?12?11? GHTF Study Group 3 ... 2.5 Manufacturer (GHTF SG1 N055R6 section 4.1). ... 2 GHTF/SG4/N28 Guidelines for Regulatory Auditing of Quality ...
GHTF/SG3/N18:2010. FINAL DOCUMENT. Global Harmonization Task Force. Title: Quality management system –Medical Devices – Guidance on corrective.
the subject as GHTF/SG1/N043:2005 Labelling for Medical Devices. Study Group 1 of the Global Harmonization Task Force (GHTF) has prepared this.
2012?5?16? Global Harmonization Task Force. (revision of GHTF/SG1/N29:2005). Title: Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic ...
2012?11?9? GHTF Steering Committee Final Document GHTF/SC/N4:2012 (Edition 2) ... Definitions which appear in GHTF Final Documents
Authoring Group: GHTF Study Group 3. Endorsed by: The Global Harmonization Task Force. Date: May 20 2005. Abraao Carvalho
GHTF/SG1/N43:2005. FINAL DOCUMENT. Title: Labelling for Medical Devices. Authoring Group: Study Group 1. Endorsed by: The Global Harmonization Task Force.
GHTF Study Group 3 SG3/N15R8 Page 2 of 23 Risk Management Guidance IMPLEMENTATION OF RISK MANAGEMENT PRINCIPLES AND ACTIVITIES WITHIN A QUALITY MANAGEMENT SYSTEM 1 Introduction 1 1 Purpose 1 2 Scope 2 Definitions 3 General 3 1 Documentation 3 2 Communication 4 Management Responsibilities 5 Outsourcing 6 Planning 7 Design and
The primary way in which the Global Harmonization Task Force (GHTF) achieves its goals is through the production of harmonized guidance documents suitable for implementation or adoption by member Regulatory Authorities as appropriate taking into account their existing legal framework or by nations with developing regulatory programmes
GHTF/SG3/N18:2010 FINAL DOCUMENT Global Harmonization Task Force Title: Quality management system –Medical Devices – Guidance on corrective action and preventive action and related QMS processes Authoring Group: Study Group 3 Date: 4 November 2010 Dr Larry Kelly GHTF Chair
GHTF/SG3/N17:2008 FINAL DOCUMENT Title: Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers Authoring Group: GHTF Study Group 3 Endorsed by: The Global Harmonization Task Force Date: December 11 2008 Dr Roland Rotter GHTF Chair
GHTF Study Group 3 - Quality Management Systems Process Validation Guidance – January 2004 Page 8 While the output of a process may be verifiable application of software used in that process should be validated for its intended use 4 Statistical methods and tools for process validation