GHTF SG3 - Risk Management Principles and Activities ...

'Software as a Medical Device': Possible Framework …

The objective of this document is to introduce a foundational approach, harmonized vocabulary and general and specific considerations for manufacturers, regulators, and users alike to address

GHTF SG4 - Guidelines for Regulatory Auditing of …

Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 5: Audits of manufacturer control of suppliers

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Software as a Medical Device (SaMD): Key definitions

IMDRF/SaMD WG/N10FINAL:2013 _____ 5.0 Key Definitions 5.1 Software as a Medical Device

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GHTF SG2 Medical Devices: Post Market …

February 2009 3 / 13 Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form: GHTF/SG2/N79R11:2009

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GHTF SG1 Safety and Performance of Medical …

Essential Principles of Safety and Performance of Medical Devices Study Group 1 Final Document GHTF/SG1/N68:2012 November 2nd, 2012 Page 2 of …

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GHTF SG1 - Summary Technical Documentation …

Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of IVD Medical Devices (STED)

GHTF SG1 - Label and Instructions for Use for …

Label and Instructions for Use for Medical Devices Study Group 1 Final Document GHTF/SG1/N70:2011 September 16 th, 2011 Page 4 of 17 1.0

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PROPOSED REVISED DOCUMENT - IMDRF

SG1(PD)/N011R20 PROPOSED REVISED DOCUMENT Global Harmonization Task Force Title: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices

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Nonconformity Grading System for Regulatory …

Nonconformity Grading System for Regulatory Purposes and Information Exchange Study Group 3 Final Document GHTF/SG3/N19:2012 November 2nd, 2012 Page 3 of 16 Preface

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GHTF SG5 Key Definitions and Concepts - IMDRF

Clinical Evidence – Key Definitions and Concepts Study Group 5 Proposed Document SG5(PD)N1R7 April 26, 2006 Page 3 of 8 Preface The document herein was produced by the Global Harmonization Task Force, a voluntary group

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Test Method Validation for Medical Devices

A few of the above warning letters from FDA reminded the medical device manufacturers that ignoring medical device test method validation may result in product recalls and negative financial impacts. The present and future market scenario has a clear defined objective of projecting quality as the sole weapon for every medical device ...

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Cleaning Validation for Medical Device Manufacturing

§820.72 Inspection, measuring, and test equipment (ISO 13485:2003 7.6) (a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of

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Chip-on-Glass LCD Driver Technology - NXP

Progress in Liquid Crystal Display (LCD) medical imaging technology has led to its increasing adoption for diagnostic viewing of medical images. ... Thus manufacturers must find ways to cut cost wherever possible. One way to cut ... inspection and verification: – Only verification of the flex panel connection (FPC) is

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Managing Medical Devices - GOV.UK

Managing Medical Devices January 2021 Page 7 of 46 2.4 Records Good record keeping is essential for the safe management of medical devices. All the aspects of medical device management covered within this guidance document require some degree of record keeping. The records should be maintained within one system wherever possible.

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Medical Device Reporting (MDR) 21 CFR Part 803

4 Medical Device Reporting 21 CFR 803 • §803.3 MDR Reportable Event means 2.An event that manufacturers or importers become aware of that reasonably suggests that

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US Food and Drug Administration - FDA Medical Device ...

An Educational Forum co-sponsored by the US Food and Drug Administration and the FDA Medical Device Industry Coalition April 2, 2010 Arlington, Texas USA

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#8a Medical equipment maintenance - WHO

2 Medical equipment maintenance programme overview 6 Implementation 35 6.1 Inspection and preventive maintenance 35 6.1.1 IPM procedures 35 6.1.2 …

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Medical Equipment Management Plan - Duke University

The Medical Equipment Management Plan defines the mechanisms for interaction and oversight of the medical equipment used in the diagnosis, treatment, and monitoring of patients. The related policies and procedures govern activities from selection and acquisition to incoming inspection and maintenance of medical equipment.

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Guidance for Notified Bodies auditing suppliers to medical ...

NBOG’s Best Practice Guide applicable for AIMDD, MDD, and IVDD 2010-1 NBOG BPG 2010-1 Page 1 of 7 Guidance for Notified Bodies auditing suppliers

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