Principles and Practices for Medical Device Cybersecurity

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 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 …

  Performance, Devices, Medical, Safety, Safety and performance of medical, Safety and performance of medical devices

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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Software as a Medical Device (SaMD): Key definitions

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

  Devices, Medical, Software, Software as a medical device

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

  Devices, Label, Document, Medical, Instructions, Label and instructions for use for, Label and instructions for use for medical devices

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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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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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': 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 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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日付 曜日 開始時間 終了時間 ルーム セッション セッション …

50 2月3日 （木） 17:30 18:30 b 一般口演61 aiとsamd 51 2月3日 （木） 18:40 19:40 a 一般口演55 血栓回収（病態） 52 2月3日 （木） 18:40 19:40 b 一般口演42 医療資源寡少地域における急性期脳卒中治療 53 2月3日 （木） 19:50 20:50 a 一般口演54 血栓回収6

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医療分野研究成果展開事業 先端計測分析技術・機器開発プロ …

(E) ソフトウェアを用いた診断・治療の実現（特にSaMD） (F) 遠隔・在宅診断・治療への対応 ＜革新的な治療・診断法の創出＞ (G) 従来にはない革新的な治療や低侵襲治療の実現 (H) 従来にはない革新的な診断の実現や高度化された画像・光学診断の実現

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令和2年12月24日 厚生労働省医薬・生活衛生局医療機器審査 …

as a Medical Device; SaMD）及びセキュリティが適用範囲であることが示され、 ユーザビリティに関するリスクに適用することが示されていることに留意する こと。また、改正後のJISでは従来の「誤使用」は「使用エラー」と修正され、

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